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Alzheimer’s disease has affected my family, and I can’t help but feel a deep sense of dread about possibly facing it myself. Even small lapses in memory, like forgetting a familiar route or misplacing a word, trigger anxiety for me.
Recently, the FDA approved the first-ever drug specifically for Alzheimer’s. Much like with the COVID vaccine, it will take time to fully understand its broader implications, but I am keen to see what unfolds.
The approval sparked significant controversy within the FDA, leading to the resignation of several committee members. Dr. Sarah Reynolds from Johns Hopkins University, along with neurologists Ryan Smith from Cleveland Clinic and Linda Patel from Stanford University, stepped down from the FDA’s Advisory Committee for Neurological Drugs over the expedited approval of this treatment.
However, the news has brought hope to many patients, caregivers, and healthcare providers. The drug, known as Aduhelm (generic name: aducanumab), is designed to assist those in the early stages of Alzheimer’s and to slow the disease’s progression.
The controversy stems from the fact that many committee members felt the drug had not undergone sufficient clinical testing. Notably, 10 out of the 11 members voted against its approval. Yet, it passed through an accelerated approval process that allows the drug to be available while still requiring additional post-approval studies to confirm its effectiveness. This phase 4 trial is where the concerns lie.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, mentioned to NPR that the agency believed the benefits of Aduhelm outweighed the potential risks. But doesn’t this apply to all medications? There’s always some level of risk involved. If I were diagnosed with Alzheimer’s, I’d want to give it a shot.
Patients involved in the trials are already reporting positive changes. For instance, Sarah Thompson, diagnosed with early-stage Alzheimer’s in 2016, shared with CNN that she finds her glasses more easily now. She remarked, “I can’t say I notice a difference every day, but overall, I feel I’m doing better at locating my glasses — little things like that.” Thompson participated in clinical trials starting in 2018, paused when the drug was temporarily halted, and resumed earlier this year.
NPR reporter Jon Hamilton highlighted the excitement surrounding this drug: “Aduhelm is groundbreaking because it does more than merely alleviate Alzheimer’s symptoms; it actually targets an underlying disease process by reducing the amyloid plaques that accumulate in the brain. The catch, however, is that while removing these plaques may not necessarily prevent memory loss or cognitive issues, one significant study indicated it does, while another suggested otherwise.” It’s clear that Alzheimer’s is a challenging condition, and I wholeheartedly support any effort to alleviate its effects.
According to the Alzheimer’s Association, over 6 million individuals are currently living with the disease, which disproportionately affects women and Black individuals compared to men and white individuals. Alzheimer’s claims more lives each year than breast cancer and prostate cancer combined. On average, those diagnosed after age 65 live about eight years post-diagnosis.
While I’m not a medical professional, isn’t taking risks part of the process in medicine? Researchers and doctors conduct experiments, test treatments, and deliver them to the public—just look at the rapid development of COVID vaccines. Within months, we had several COVID vaccines available for widespread use. The last Alzheimer’s medication to gain FDA approval was back in 2003.
The financial burden of copays also raises concerns regarding this new drug. With potential annual costs reaching up to $11,500, it becomes a significant expense, particularly for older Americans living on fixed incomes.
Despite its flaws, Aduhelm offers patients and their families a glimmer of hope, something that is often scarce with an Alzheimer’s diagnosis. In my view, if a medication can provide that, it’s worth exploring.
For more insights, you may also find value in our other blog post here as well as resources from Make a Mom about home insemination, which offer valuable information on this subject. Additionally, for a deeper understanding of related processes, check out this excellent resource on in vitro fertilisation.
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Summary:
The FDA’s recent approval of Aduhelm, the first drug targeting Alzheimer’s disease, has sparked both excitement and controversy. While some experts question the adequacy of clinical trials, many patients report positive outcomes from early use. As the drug offers a potential new avenue for hope in managing Alzheimer’s, its high cost and the necessity for further studies remain pressing issues.
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