Every day, Arthena Caston prays for more time.
More time to get to know her grandchildren and get them to know their “Iya”.
More time to share many Christmases with his family.
In March 2016, Caston, who lives in Macon, was diagnosed with early stage Alzheimer’s disease at 51, which slowly decreases a person’s memory and cognitive abilities.
Today, she and other patients cling to the hope that a drug to slow the effects of the disease will help them.
The United States Food and Drug Administration recently granted fast track approval for the use of aducanumab, sold under the brand name Aduhelm and developed by Biogen and a Japanese company, for the treatment of Alzheimer’s disease, a progressive disease that affects 6.2 million people in the country.
Aduhelm, which would be given to early-stage patients by infusion once a month, is designed to slow the progression of the disease.
This is the first drug treatment for Alzheimer’s disease approved by the federal agency in almost two decades, although its path to approval has been controversial and the rest.
The fast-track FDA approval has given hope to some patients and their families. Others, however, doubt the efficacy and safety of the drug.
“If that gives me an hour, a day, five days or a year, then you’re going to say, ‘Yeah, give it to me,’ said Caston, a retired insurer who is also a board member of administration of the Alzheimer’s Association of Chicago.
She was one of several who shared their stories about living with the debilitating disease on a Zoom call earlier this year with FDA officials and others.
She told them about her grandchildren, two who were not born when she was diagnosed and a third who will be born this year. Her daughters and their spouses told her that they had decided to have children so that she could get to know them and them, her.
“I am very excited,” said Linda Davidson, executive director of the Alzheimer’s Association, Georgia Chapter. “This is the first drug treatment that offers us a new future and a chance to slow the progression of the disease. We know it is not a cure. It is a treatment and we know that it is only used for people with mild cognitive impairment due to Alzheimer’s disease.
About 150,000 in Georgia have been diagnosed with the disease, according to the association. By 2025, that number is expected to increase by 26.7% to 190,000 people. Georgia is in the top 10 states for increasing prevalence, largely due to an aging population. Between 2000 and 2030, Georgia’s population of people aged 65 and over will increase by 143%, according to the state’s Division of Aging Services.
The drug’s journey to FDA approval was filled with controversy, including concerns about its effectiveness, side effects, high cost, and the relationship between Biogen, the drug’s maker, and the federal agency. At the local level, there are also questions about the number of infusion centers in Georgia and whether they will be located in rural areas as well as in large cities.
Just this week, Dr David Knopman, a neurologist at the Mayo Clinic, told CNN he resigned from the central and peripheral nervous system drug advisory committee to protest the FDA’s decision.
“It’s a very big decision, but if it is a game-changer I think we still have to see if the product is safe and effective and this is the basis of so much controversy around its approval,” said Dr Caleb Alexander, professor at Johns Hopkins. Bloomberg School of Public Health at the University. “It is not clear whether or not lower beta-amyloids result in improvement of critical symptoms of Alzheimer’s disease. He is worried about side effects and prices, which he says will “break the bank” for health insurers and patients.
The drug is expensive and questions arise as to whether Medicare and Medicaid or private insurers will pay and how much. Biogen said the drug would cost around $ 56,000 for a typical year of treatment, and said the price would not be increased for four years.
Lisa M. Renzi-Hammond, associate professor at the University of Georgia and co-director of the Cognitive Aging Research and Education Center, called aducanumab “just one more tool in the toolbox.”
Yet she is cautious. Renzi-Hammond advises patients to speak with their doctor to see if they are good candidates for the drug. It targets amyloid plaque.
“We’re still learning about variations in Alzheimer’s disease and dementia,” she said. “Some people take medicine and it works miraculously; some people take medication and don’t notice a difference at all. I don’t see how this drug is any different, but (for those who see benefits) it can provide incredible relief. We will learn more about the drug when it is more widely used.
Last year, Public Citizen called for an investigation into the collaboration between the FDA and Biogen.
“The FDA decision shows a blatant disregard for science and gutters the agency’s standards for approving new drugs,” according to a statement by Dr. Michael Carome, director of the Public Citizen’s Health Research Group, on the website of the watchdog. “As a result of this reckless action, the credibility of the agency was irreparably damaged.”
He added that the approval was based on “seriously flawed analyzes of two identical Phase 3 trials that were stopped mid-term because a preliminary review of the data found that the trials, if they continued until their term, were unlikely to show the drug to be of benefit to Alzheimer’s patients. One trial showed no benefit, and the other suggested only minimal possible benefit at a high dose. “
Dr Allan Levey, chair of the neurology department at Emory University and director of the Alzheimer’s Research Center, said he “wouldn’t call the drug itself a game changer, but I thinks the moment is the start of a game-changing moment. I think this is a really, really crucial step forward.
He and others have stressed that patients and their families shouldn’t expect a cure, which they don’t, and that it won’t work for those further along in their diagnosis.
“I know our patients and their families are desperate. What I don’t want is for them to have false expectations, ”he said.
He said the FDA would let doctors prescribe the drug, with one more study to do. If the additional studies turn out to show no clinical benefit, the FDA may withdraw the approval.
Columbus Memory Center director Dr Jonathan L. Liss said he was someone who “waited 30 years for this moment in the field.”
He tells patients that the treatment could extend their independence, if they qualify, and already has about 20 patients “in line to get the drug”; others have “passed the point where they would be eligible.”
This, however, does not diminish the hopes that some families have placed in Aduhelm.
Robert Reid’s wife Kim, then 50, was diagnosed with early Alzheimer’s disease on June 15, 2017.
Kim Reid, then freight manager for a logistics company, noticed that she was having problems tracking and managing the various shipments. Her primary care physician said it was menopause or just an “aging” issue. He finally took the doctor aside and ordered more tests.
Several specialists later, Hampton residents were diagnosed. Robert Reid retired from an engineering company to help take care of his wife. “It’s very difficult on a daily basis to make sure she doesn’t go for a walk or to get her to exercise and do things for herself,” he said. “It’s a 24/7 job.
He researched the new drug and “the obstacles here and there, but anything that will potentially improve the quality of life will benefit the family as a whole.”
He plans to discuss the possibility that she will receive the IVs at her next appointment. He knows that the progression of the disease is not the same for everyone and there are also other tests that must be done before a patient is considered a good candidate.
“There are still a lot of questions,” he said.
The drug will not help everyone.
When Keondra Williams heard about the drug’s approval, the Powder Springs woman immediately called her father’s doctor.
It was far, she knew.
Her father, Duvall Watson Sr., 65, has advanced Alzheimer’s disease and is now in hospice care.
His illness was too advanced. He no longer communicates or responds to stimuli such as jazz music or the sounds of his favorite band, Earth, Wind & Fire. He’s just looking down.
“It’s a very tough disease,” she said. “It went through our family emotionally and financially. “
And although the drug did not help his father, “I hope it will be useful for another family. My prayer is that they finally find a drug that cures Alzheimer’s disease and that people don’t go through the same things we do. “
“Ultimately, in the future, we are not going to worry about the number of people who die each year and each day from Alzheimer’s disease,” she said.
Caston is still traveling and giving speeches.
“I am so blessed to know that I have passed five years (since diagnosis) and am still very cognitive,” she said. “If someone gives me the chance to extend this, I have nothing to lose. I wonder every day, when I wake up, will today be the last day I can talk to people and show them who I am?