New drug stirs FDA controversy
For the first time in 20 years, the Food and Drug Administration has approved a first-of-its-kind drug for Alzheimer’s that treats the disease and slows its progression.
Alzheimer’s is a form of dementia, which is a disease that attacks brain cells. Dementia is a more general term, and some people who have cognitive loss from dementia do not have Alzheimer’s.
First named aducanumab and now called aduhelm, the drug is not a cure for Alzheimer’s. But it is the first new drug that could be effective at slowing the progression of the disease that robs people of their brain function.
That’s the good news.
The bad news is that it has generated controversy over whether it should have been approved by the FDA. The flare-up has prompted three members of an FDA advisory board to resign in protest.
The board members said the approval sets a poor precedent for giving other drugs the greenlight. They also point to the drug’s high cost and its potential impact on healthcare costs.
Dr. DeWayne Nash of Santa Barbara is keenly aware of the controversy, and there is no ambiguity as to where he stands on the issue.
“The FDA did the right thing by approving it for use in early Alzheimer’s since it shows that it may decrease cognitive decline in these patients by 22%,” Dr. Nash told the News-Press. “I’ve read all the negative reviews. I have elected to turn them off. The decision is made.
“Now let’s see how well it works,” he said. “The drug aduhelm gives us in the Alzheimer’s world one thing — some hope.”
The retired family physician was diagnosed with early mild cognitive impairment, a precursor to Alzheimer’s, in December 2010. He was in the aduhelm study conducted by Biogen for about 25 weeks, receiving 18 months of placebo and seven months of aduhelm at UCLA.
“It was supposed to be continued a year ago, but it was delayed by the pandemic. I restarted the infusions this summer,” he said.
Agreeing with Dr. Nash about the efficacy of the drug is Kathryn Croskrey, executive director of the Alzheimer’s Association, SanDiego/Imperial Chapter.
“Aduhelm may not be a perfect drug, but it’s the first step, and just like other diseases, the first step leads to other steps that will focus on newer and better therapies,” she told the News-Press.
One of the issues in the controversy is side effects, which may include headache, dizziness, nausea, confusion and vision changes.
“All drugs have side effects,” said Ms. Croskrey. “In the FDA label, the most common side effects include amyloid-related imaging abnormalities (ARIA), headaches and falls. Your health care provider will do MRI scans before and during the treatment to monitor for ARIA, which is a common side effect that does not usually cause any symptoms but can be serious. It is typically a temporary swelling in areas of the brain that usually resolves over time.”
Dr. Nash said that the allergic reaction and brain swelling and the microbleeds were risks and side effects that were explained to him before the clinical trial.
“I signed several documents without the blink of an eye. I never thought twice about it,” he said. “If you think about it, these amyloid plaques have been in the brain for years. Now the body will be removing them from the brain, and the body and the brain are not going to like that happening. I think of it like a wound with a scab on it.
“You peel the scab off, and the wound bleeds some, then it heals. So it seems that’s what may happen when the amyloid plaques are removed.”
The price of the drug is projected to be $56,000 a year, raising serious concerns about its affordability.
“The cost will be around $4,000 plus a month, which is the cost of treatment for things like connective tissue diseases like rheumatoid arthritis or lupus or ulcerative colitis or cancer,” said Dr. Nash. “You can only imagine the rush there will be for folks to gain access to this drug. There may not be enough neurologists, infusion centers or MRI scanners to keep up with the demand.”
For aduhelm to be effective, Alzheimer’s must be detected in its early stages, and that’s one of the major challenges, according to Ms. Croskrey.
“Signs of dementia can vary greatly,” she said. “Examples include problems with short-term memory, keeping track of purses or wallets, paying bills, planning and preparing meals, remembering appointments and traveling out of the neighborhood.
“Many conditions are progressive, which means that the signs of dementia start out slowly and gradually get worse. If you or someone you know is experiencing memory difficulties or other changes in thinking skills, don’t ignore them,” Ms. Croskrey said. “See a doctor soon to determine the cause. Professional evaluation may detect a treatable condition.
“And even if symptoms suggest dementia, early diagnosis allows a person to get a maximum benefit from available treatments and provides an opportunity to volunteer for clinical trials or studies,” she said. “It also provides time to plan for the future.”
Dr. Nash considers himself lucky that he fit the criteria for early detection.
“Lucky for me, I have had seven infusions of this drug and am being reevaluated for inclusion in a study for at least two years to get aduhelm in monthly infusions,” he said, adding, “It is important for folks to keep this drug in its proper perspective. It is not a cure. It is not for all Alzheimer’s patients. It is not for folks whose Alzheimer’s has progressed too far. It has to be given early in the disease to be effective.”
He added for emphasis, “The FDA did the right thing. It gave us hope. Hope we will take every time.
“Aduhelm is the inflection point for Alzheimer’s treatment. It will be known as the one that started the Alzheimer’s treatment movement that is on the way in the future.”