There has been a lot in the news lately about aducanumab (Aduhelm), a new monoclonal antibody treatment for Alzheimer’s disease.
Alzheimer’s disease is a neurological disease and is the most common cause of dementia. It causes destructive, progressive, and irreversible changes in the brain. A common feature is the accumulation of a protein called amyloid-β in the form of plaques and tau tangles. Both are thought to cause cell death, but they have not yet been shown to be the cause of Alzheimer’s disease.
Aducanumab (Aduhelm), a drug that reduces amyloid-β plaques, was approved by the FDA on June 7, 2021 for treatment of all stages of Alzheimer’s disease. The approval was quite controversial for several reasons.
- Many experts are concerned that accelerated approval of aducanumab without convincing evidence is premature, especially since it was only tested on those with early Alzheimer’s disease but was approved for all stages. In fact, there is no evidence at all that aducanumab is effective in patients with advanced Alzheimer’s disease.
- The government is now looking at the issue since Alzheimer’s disease primarily occurs in seniors and Medicare will be picking up most of the tab for a medication that may have little benefit.
- The Boston Globe reported unofficial meetings between the manufacturer and an FDA director that may have influenced the decision.
The reason for the controversy can be confusing, so I will try and explain the different sides of the issue to help you understand what the fuss is about. There are basically three perspectives to consider when breaking down this issue.
- Those who believe there was not enough good evidence that aducanumab improves patients with Alzheimer’s disease to approve the drug, especially for use in those with advanced disease.
- Those who feel that the fact that there are no other available treatments justifies the use of aducanumab without convincing evidence and despite the known side-effects.
- Those who are concerned that the healthcare system cannot afford the $58,000 yearly cost of medication, along with the cost of brain-imaging tests, infusions, and provider visits, especially if the benefits are only subtle.
Basing medical treatments on solid evidence is of major importance to healthcare providers. There are too many examples of unhelpful