artificial insemination kit for humans
Alzheimer’s disease has touched my family, and I admit, the thought of developing it myself fills me with dread. I often experience moments of panic when I forget small details, like where I parked or a word I’ve used countless times before.
Recently, the FDA approved the first new drug specifically for Alzheimer’s treatment — a significant milestone much like the arrival of the COVID vaccine. While it will take time to evaluate the drug’s overall effects, I am eager to see how it will help those affected.
This approval sparked considerable debate within the FDA, leading to the resignation of some committee members. Dr. Lisa Reynolds, a Harvard Medical School professor and director of the Regulatory and Therapeutics Program at Brigham and Women’s Hospital, along with neurologists Thomas Green of the Mayo Clinic and Sarah Mitchell of Washington University in St. Louis, stepped down due to concerns over the speed of the approval process.
However, this new drug has brought a wave of excitement among patients, caregivers, and medical professionals. Known as Aduhelm, or aducanumab in its generic form, it targets individuals in the early stages or with mild symptoms of Alzheimer’s and aims to slow the disease’s progression.
Controversy surrounds the approval, as many committee members felt the drug lacked sufficient clinical trial data. In fact, 10 out of the 11 members voted against its approval. So, how did it get approved? The drug was granted accelerated approval, allowing it to reach patients sooner while still requiring a follow-up study to confirm its effectiveness in what’s known as phase 4 of the approval process.
Dr. Patrizia Cavazzoni, director of the FDA’s evaluation and research center, stated that the agency determined the benefits of Aduhelm outweighed the risks involved. But isn’t this the case with all medications? All drugs carry some level of risk, and if I were facing Alzheimer’s, I would want to explore every option.
Patients have started to report positive outcomes from the trials. Take the example of Emma Turner, who shared with CNN that she can now locate her glasses more easily. Diagnosed with early-stage Alzheimer’s in 2016, Turner mentioned, “I can’t say I notice a change every day, but overall, I feel I’m doing better when searching for my glasses.”
Jon Hamilton, a reporter for NPR, aptly pointed out, “This drug has generated excitement because it is the first approved treatment that does more than just alleviate Alzheimer’s symptoms. It aims to address an underlying issue by reducing amyloid plaque buildup in the brain. However, removing this plaque may not necessarily prevent memory loss or cognitive decline. Some studies indicate it does help, while others suggest it does not.” Given the debilitating nature of Alzheimer’s, I fully support any efforts to provide relief to those suffering.
According to the Alzheimer’s Association, over 6 million Americans are currently living with this disease, disproportionately affecting women and Black individuals compared to their male and white counterparts. Alzheimer’s leads to more deaths each year than breast and prostate cancer combined, with an average life expectancy of eight years post-diagnosis for those aged 65 and older.
While I am not a medical expert, I believe that medicine involves taking calculated risks. Researchers and doctors conduct trials, test medications, and release them to the public — just like we saw with the COVID vaccines. It took mere months to develop several effective vaccines for COVID-19. The last Alzheimer’s drug approved prior to this was in 2003.
Another concern is the financial burden associated with this treatment. With annual costs reaching up to $11,500, Aduhelm poses a significant challenge for older Americans living on fixed incomes.
Despite its shortcomings, Aduhelm offers a glimmer of hope for patients and families grappling with an Alzheimer’s diagnosis — something that’s often hard to find. If a medication can provide that hope, I believe it is worth pursuing.