Why the new FDA approved Alzheimer's drug is controversial, yet groundbreaking

Posted at 9:44 PM, Jun 07, 2021

(WXYZ) — It's a big day for Alzheimer's patients and their families after the FDA approved a new drug to fight the disease. It's the first approved in roughly 20 years.

RELATED: FDA approves drug for use in fighting Alzheimer's despite lingering questions from key panel

However, the approval didn’t come without controversy over the effectiveness of the drug, with an advisory panel urging the FDA to reject its approval.

But some doctors and organizations are still thrilled with this news saying it provides a huge sense of hope for thousands of Michigan families.

"How long have you been married?" 7 Action News Reporter Brett Kast asked Jim Mangi from Saline.

"Forty-five years," Mangi said with a smile. "But of course if you asked her in her better days, far too long.”

After nearly half a century together, Jim Mangi still smiles thinking of his wife Kathleen. But all jokes aside, their time together has been far too short after she was diagnosed with Alzheimer’s 14 years ago, at just 58 years old.

“She has completely lost the ability to walk, she has almost completely lost the ability to talk," Mangi said. "But I am happy to report she has not lost the ability to smile.”

Their struggle is felt by thousands of families across Michigan, which according to the Alzheimer's Association has roughly 190,000 patients struggling with the disease. Thousands more are struggling by their side.

“We live the disease with her," said April Daenzer, whose mom has Alzheimer's. "We don’t have it but we are experiencing it with her.”

Daenzer’s mom Jan Parisi was diagnosed five years ago. She had just been elected mayor of Hazel Park but had to resign just one year later.

“It’s hard to watch her decline so fast,” Daenzer said.

That’s why news of a new drug means so much to these families. It’s the first FDA-approved drug for Alzheimer's in 20 years, and the first of its kind.

“The Alzheimer's Association was very much in favor of the drug being approved really from the perspective of it is the first and only drug that actually treats the underlying biology of the disease,” said Jennifer Lepard, president and CEO of the Alzheimer's Association Michigan Chapter.

The drug works to remove a harmful protein in the brain believed to be one of the underlying causes of Alzheimer's. Its goal is to slow the onset of the disease.

“We’re looking right now for anything that can buy the patient more time," said Dr. Jonathan Fellows, a Neurologist at the Michigan Institute for Neurological Disorders in Farmington Hills. "What I mean by that is if we can maintain the patient at a certain level and then a new groundbreaking treatment comes along, later on, that's a wonderful thing.”

Dr. Fellows says while this drug is not a cure, he’s excited to start prescribing it to his patients.

“We have many patients already lined up that we have sort of stratified that we believe will be excellent candidates for this drug,” Dr. Fellows said. "We’ve had that narrative, had that discussion, and they’re excited to be a part of this journey with us.”

But the approval comes with skepticism. The latest study showed the drug slowed cognitive decline by only 22%, not effective enough for many experts but effective enough for the FDA and the Alzheimer's Association.

“We felt based on the data that had been accumulated to date, and based on the fact that there isn’t anything else, this really made sense to approve,” Lepard said.

The drug is only for patients in the very early stages of Alzheimer's, meaning it won’t help Kathleen or Jan. However, their families know what it means for other families if it leads to a few more months with their loved one.

“My family and I would be so happy to have her right at this spot for 6 more months,” Daenzer said.

“I can't tell you what I would have given 12 years ago, 14 years ago for a drug that really made a difference,” Mangi said.

With this approval also comes a few caveats. The FDA says it will continue doing studies on the effectiveness of the drug and could take it off the market if it fails to produce results. The drug also carries a hefty price tag, $56,000 a year. That’s just for the drug, not including the cost for tests and doctors' visits. However, Medicare and insurance are expected to cover the drug.