Alzheimer’s runs in my family. Truth be told, I am terrified of getting it. I even have mild anxiety attacks when I forget something or a route to a store I’ve visited many times, or simply can’t remember a word.
Earlier this month, the first drug for Alzheimer’s was approved by the FDA for use. Like the COVID vaccine, it will take time to learn of the impact the drug has on us as a whole, but I am eager to find out.
The approval of the drug caused quite the stir within the Food and Drug Administration, resulting in some stepping down. Dr. Aaron Kesselheim, a professor at Harvard Medical School who is also director of the Program On Regulation, Therapeutics, And Law at Brigham and Women’s Hospital, and neurologists David Knopman of the Mayo Clinic in Minnesota and Joel Perlmutter of Washington University in St. Louis, all resigned from the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee because of the accelerated approval of the drug.
However for many, this drug brought excitement for patients, caregivers, and doctors. The brand name is called Aduhelm and the generic name is aducanumab. The drug is meant to help those with early stages or mild Alzheimer’s symptoms, as well as slow its progression.
The controversy comes because some on the approval committee said that the drug did not go through enough clinical trials. Of note, 10 of the 11 committee members voted against approving the drug, so why the approval? The drug went through an accelerated approval process, which will make it available to companies for patients and will require what is known as a post-approval study. This process gives an additional trial to prove effectiveness in phase 4 of the approval process. This is where the committee hits a snag.
Director Patrizia Cavazzoni of the center for evaluation and research department within the FDA told NPR that her agency “concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.” But isn’t this the case with all medications? There is some risk, no matter what. If I had Alzheimer’s, I’d want to try it.
Patients who participated in the trial are already seeing benefits — like Jenny Knapp, who told CNN that she can now find her eye glasses a little easier. Diagnosed in 2015 with early stages of Alzheimer’s, Knapp noted, “I can’t say if I noticed it on a daily basis, but I do think overall, I’m doing much better in terms of looking for where my glasses are — things like that.” Knapp began the clinical trials in 2019, stopped when the drug was put on hold, and restarted the trial earlier this year.
Jon Hamilton, a reporter for NPR, put it well: “This drug has generated all kinds of excitement because it is the first approved drug that does more than just relieve the symptoms of Alzheimer’s. This drug actually affects an underlying disease process by reducing the amount of sticky amyloid plaque that builds up in the brain. The catch is that removing this plaque may not actually help patients avoid memory loss and thinking problems. One big study showed that it did. Another showed that it didn’t.” We know that Alzheimer’s is a debilitating disease; I am all for giving relief to its suffers.
According to the Alzheimer’s Association, over 6 million people suffer from the disease. It is a disease that affects women and Black people more than men and white people. Alzheimer’s kills more people each year than breast cancer and prostate cancer combined. On average, those who suffer from Alzheimer’s who are 65 years or older last about eight years after diagnosis.
I am no expert, but in medicine, we take chances, right? Researchers and doctors run trials, they test medications, and they get them out to the public — just look at the COVID vaccine. In the span of months, we had three different COVID vaccines, some stronger and more reliable than others, ready to be shot into the bodies of millions of people worldwide. The last medication to be approved for Alzheimer’s was in 2003.
The burden of copays is another issue presented about this drug. Co-pays are a pain in the ass anyway, but this drug can cost the patient up to $11,500 a year. So, it ain’t cheap, especially for older Americans on a fixed income.
Regardless of its imperfections, Aduhelm is giving patients and their families something that’s hard to come by with an Alzheimer’s diagnosis: hope. And if a drug can do that, I think it’s worth trying.
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