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Vermonter who took part in trial of Alzheimer's drug excited about FDA approval

Published: Jun. 8, 2021 at 12:05 AM EDT|Updated: Jun. 8, 2021 at 6:07 AM EDT
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BURLINGTON, Vt. (WCAX) - The FDA on Monday approved a new drug for Alzheimer’s for the first time in nearly 20 years. The treatment is driving some debate over its effectiveness.

According to the Alzheimer’s Association, there are about 13,000 Vermonters living with Alzheimer’s. This new drug is called Aducanamab or Aduhelm and is the first to start attacking some of the underlying biological causes of the disease. It’s designed for people with mild Alzheimer’s and is not a cure, but is hopefully a sign of progress being made against the disease.

“It’s a miracle, it’s a joyous thing in our lives and now it’s going to be a joyous thing in a lot of people’s lives,” said Kate Sullivan, whose husband is living with Alzheimer’s.

Tom Sullivan of Burlington was diagnosed with Alzheimer’s back in 2016 and was able to get into the trial for this newly approved FDA drug. He and his wife, Kate, say over the course of taking the drug infusions once monthly for years, say his cognitive tests have not declined while taking the drug and his day-to-day life has improved.

“Our conversations are better just between the two of us because it’s harder to have good conversations when you have these issues that are flying around in your brain and such,” Tom said.

An independent panel of neurological experts strongly cautioned the FDA against approval for the drug due to side effects such as brain swelling and bleeds in 40% of trial participants. The FDA approved the drug on an accelerated approval timeline, meaning another trial has to occur while it’s publicly available, and if clinical results are not shown then its FDA approval could be rescinded.

FDA advisor Dr. Caleb Alexander of Johns Hopkins Bloomberg School of Public Health says he’s skeptical about the consistency of evidence.

“I think the jury is still out on whether it works,” Alexander said. “There is a clear standard that manufacturers have to meet in order to gain market access and in this instance, I think the evidence is quite murky as to the safety and especially the effectiveness of this product.”

Despite the criticism, the CEO of the Alzheimer’s Association of Massachusetts and New Hampshire, Jim Wessler, says this could be a good sign of other drugs coming in the future.

“There are many drugs in the pipeline. Somebody has to be first and we do think the science warrants approval. We are very excited about it and we look very forward to seeing new candidates go in front of the FDA in years to come,” Wessler said.

Tom Sullivan says he experienced one very small bleed, however it went away very quickly. He says besides that he has had no other side effects, and the time with his family and wife is worth the risk.

“It’s hard to express it but it’s like half of my life would have been gone if I couldn’t interact with my grandchildren and my wife,” Tom said.

“It really changes your perspective on life,” Kate said. “It changes your perspective on the disease because it gives you hope.”

While Tom Sullivan’s experience so far has been a positive one, he’s only one patient. If you were also involved in this study, feel free to reach out to us. We’d love to hear from you about your experience.

Related Story:

FDA approves much-debated Alzheimer’s drug panned by experts

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