ABC57 Investigates: Buying Time, new Alzheimer's drug coming to Michiana
SOUTH BEND, Ind. -- Currently, around six million people in the United States are living with Alzheimer’s Disease.
It’s a number that’s expected to rise, more than doubling by 2050.
Now, the FDA has approved a controversial new drug, but questions surround whether or not it works.
We spoke experts to find out and we also talked those who have seen the progression of the disease in their own families on if they’d take it.
They say time waits for no one.
But for people with Alzheimer’s Disease that’s especially true because for them, time is stolen.
“She was just such a beautiful, beautiful woman inside and out, she really was,” Norene Smith says of her mother-in-law, Patricia Smith, who died of Alzheimer’s Disease.
Inside Patricia Smith’s brain cells that beauty weaved a tangled web of twisted fibers caused by a naturally occurring protein that sticks or clumps. There are two types of proteins that can clump, ultimately killing cells, but the result is the same, Alzheimer’s Disease
“It was a little bit shocking because we weren’t thinking that,” Norene Smith says of her mother-in-law’s diagnosis.
Elkhart Neurologist and the Director of Indiana Medical Research Dr. Thomas Vidic calls Alzheimer’s Disease a hidden epidemic “because these are not the people you see at the grocery stores.”
But a new drug called aducanumab seeks to remove the buildup of one of those proteins forming amyloid plaques.
It’s something Dr. Vidic and the Indiana Medical Research Arm have been looking into with similar compounds for almost a decade.
The goal seems simple enough.
“If we can get the amyloid out [of the brain], maybe the brain won’t keep deteriorating,” Dr. Vidic explains.
Hopefully, that would give Alzheimer’s patients, and their families, more good time.
“Neurons are post-mitotic, meaning we can’t regenerate them once they’re dead,” Dr. Brian Blagg, the Director of the Warren Center for Drug Discovery at the University of Notre Dame, explains.
Aducanumab is NOT a cure and many doctors aren’t sure it even works. Dr. Blagg is skeptical.
“It doesn’t make a lot of sense to me why it would show promise,” Dr. Blagg says.
Dr. Blagg is basing his opinion off what he’s read about the drug online and his scientific background.
“They skipped Phase Two of clinical trials, which is unusual, and then Phase Three wasn’t going well, and then they came back and re-analyzed the data and said it did go well,” Dr. Blagg says.
“We see the amyloid leaving the brain, but we don’t see the person improving,” Dr. Vidic says.
Back in November 2020, an FDA Advisory Panel voted against recommending the drug, but a month ago, in June 2021, that same panel changed its mind, “saying benefits outweigh risks.” The FDA fully approved it on an accelerated basis, something the federal agency has done with drugs in the past.
“The point with these accelerated approvals is to get them out to people with the hopes that they benefit people,” Dr. Blagg says, pointing to the coronavirus vaccines as a good example.
When it comes to Alzheimer’s Disease, treatments have been few and far between. Aducanumab is the first new drug on the market in almost 20 years.
“We don’t have a treatment that does anything but treat the symptoms right now,” Dr. Vidic says.
That hasn’t stopped Dr. Vidic’s approach toward treatment.
“Because the concept is good, we’re looking at it really seriously about using it for our patients,” Dr. Vidic says.
The drug also has advocacy groups, like the Alzheimer’s Association of Greater Indiana Chapter, rejoicing.
“Ultimately, it provides hope for, and could provide benefit for, those who are living with mild cognitive impairment or early dementia due to Alzheimer’s Disease,” Natalie Sutton, the Executive Director of the Alzheimer’s Association of Greater Indiana Chapter, says.
Census data from 2010 showed nearly 80,000 people suffered from dementia or Alzheimer’s Disease in northern Indiana counties over a seven-year period (2010-2017). New census data isn’t available yet, but the current numbers are expected to be much higher.
A big reason for that is the nation’s aging population.
“10,000 people in the United States turn 65 every day, Sutton says.
“It’s probably going to be the number one killer of people in time,” Dr. Bragg adds.
And most people with Alzheimer’s Disease end up at memory care facilities like Hubbard Hills in Elkhart.
“The majority of our people living here have Alzheimer’s Disease or the vascular form of dementia,” Debbie Carriveau, the Executive Director of the Living Wisdom Center at Hubbard Hills, says.
Carriveua has worked in memory care for nearly 50 years.
“It’s a growing epidemic for seniors,” Carriveua says of Alzheimer’s Disease.
These stats from the Alzheimer’s Association show the devastating effects. Since 2000, deaths from Alzheimer’s Disease have increased 145 percent and, in 2020 alone, an estimated $257 billion was spent on caregiving.
“This is a huge problem for seniors,” Dr. Vidic says. “The hope is, either with this drug or things we learn from this drug, anyway we can touch the issue and make some in-roads is important. I think the beginning of the answer is here.”
Dr. Vidic says he expects to start giving doses of the controversial new drug in Michiana within the next two months, adding some protocols for infusions are already in place.
“I don’t want to jump into this for everyone, [but] there may be some where it’s worth a try,” Dr. Vidic says.
Those who qualify for treatment may have to undergo invasive procedures like spinal taps, or other tests.
Cost could also be an issue, the drug retails at $56,000 a year, and right now, most insurance companies don’t cover it
“That will be a barrier to some people receiving access to the treatment,” Sutton says.
Norene Smith says $56,000 is not something her family could’ve afforded for her mother-in-law when she was alive.
“I don’t think we could,” Smith says. “To me that’s just outrageous.”
But Dr. Blagg looks at the drug’s price differently.
“People need to realize, someone needs to pay for all these drugs that have failed,” Dr. Blagg says.
According to the Congressional Budget Office, in 2019, pharmaceutical companies spent $83 billion on drug research and development.
Aducanumab is far from the only costly drug on the market, and both doctors say they expect insurance will eventually cover it.
“I can’t imagine how we couldn’t provide insurance cost to cover the drug,” Dr. Blagg says.
Advocacy groups are asking for coverage.
“We are advocating for coverage for this treatment,” Sutton says.
Medicare and Medicaid services recently began the process for coverage of aducanumab, though a decision could take up to nine months.
Norene Smith’s mother-in-law died in 2010 at the age of 85, but throughout the five years she served as a caregiver, she says she and her husband didn’t have anyone to turn to.
“We were thinking what are we going to do? My father-in-law had Leukemia,“ Smith recalls.
It’s why Smith now runs a support group for Alzheimer’s caregivers. Emotions are mixed between love and anger. The burden of care can be overwhelming.
“The anger comes from this place of, ‘This is my life now and I don’t really have a life because I work full-time and then I come home to this and it’s 24/7,’” Smith says of the common theme.
But she says at her last support group meeting, no one there was familiar with the new drug.
Among doctors. the hope is that the new treatment leads to something better.
And because of the FDA’s accelerated approval of aducanumab, Biogen, the drug’s maker, has until 2030 to prove the effectiveness of the drug.
“We should have an answer long before then,” Dr. Vidic says with a smile.
Aducanumab is the first glimmer of hope for those with this devastating disease.
It’s important to point out, even if you’re a candidate for treatment, and that’s confirmed through the invasive tests mentioned above, and you agree to pay, with or without insurance, there are risks associated with taking aducanumab.
Dr. Vidic says it comes with the risk of bleeding in the brain, which is why patients on the medication will need frequent MRIs.
For some, Dr. Vidic says the steeper price is watching a loved one fade away, but he agrees these are tough conversations you’ll need to have and tough decisions you’ll need to make.