Alzheimer’s disease has cast a long shadow over my family, leaving me anxious about the possibility of facing it myself. I often experience mild panic when I forget something trivial, like a familiar route or a word that momentarily escapes me.
Recently, the FDA approved the first drug specifically for Alzheimer’s, marking a significant development in the fight against this debilitating condition. Similar to the COVID vaccine, understanding the long-term effects of this new medication will take time, but I am hopeful about what it may bring.
The approval of this drug stirred significant controversy within the FDA, leading to the resignation of several committee members. Notably, Dr. Aaron Kesselheim from Harvard Medical School and neurologists David Knopman and Joel Perlmutter left their posts due to the expedited approval process.
Despite the controversy, many patients, caregivers, and healthcare professionals are excited about this breakthrough. The drug, known as Aduhelm (generic name: aducanumab), is designed to assist individuals in the early stages of Alzheimer’s and to help slow its progression.
Concerns have arisen over the drug’s approval, particularly given that the majority of the advisory committee voted against it. This leads to the question: why was it approved? The FDA utilized an accelerated approval process, which allows the drug to be available while requiring ongoing studies to assess its effectiveness in what is known as phase 4 of the approval process.
Director Patrizia Cavazzoni of the FDA’s Center for Drug Evaluation and Research stated that the agency believed the benefits of Aduhelm outweighed the potential risks. Yet, isn’t that the case for all medications? There’s always some level of risk involved. If I were diagnosed with Alzheimer’s, I would want to give this drug a try.
Patients involved in the trials are already reporting improvements. For example, Lisa Hart, who was diagnosed in 2017, shared with CNN that she has found it easier to locate everyday items like her glasses. She remarked, “I can’t pinpoint any daily changes, but overall, I feel I’m doing better when it comes to finding things.”
As NPR reporter Jon Hamilton aptly noted, “This drug has generated excitement because it is the first approved treatment that impacts the underlying disease process, reducing harmful amyloid plaques in the brain. However, there’s a caveat: removing this plaque may not directly prevent memory loss or cognitive decline.”
With Alzheimer’s affecting over 6 million individuals in the U.S., particularly impacting women and Black communities more severely, the need for effective solutions is urgent. The disease claims more lives each year than breast and prostate cancers combined, and those diagnosed often live about eight years post-diagnosis.
While I’m not a medical expert, I understand that the field is built on taking calculated risks. Just look at the rapid development of COVID vaccines, which were made available within months. The last Alzheimer’s drug was approved in 2003, highlighting the long wait for a new option.
Moreover, the financial burden cannot be ignored; the out-of-pocket cost for Aduhelm can reach up to $11,500 annually, which poses a significant challenge for many older Americans on fixed incomes.
Despite its imperfections, Aduhelm offers something that is often hard to find after an Alzheimer’s diagnosis: hope. And if a medication can provide that spark of hope, it might be worth pursuing.
For more insights on this topic, you can check out this related blog post.