Alzheimer’s drug sparks hope in patients, concern among doctors – .

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Alzheimer’s drug sparks hope in patients, concern among doctors – .


In the weeks following the approval of a new drug for Alzheimer’s disease, hopeful patients bombarded Dr. Alireza Atri with calls and emails about a treatment that sparked the both enthusiasm and skepticism.

They want to know if the drug might be right for them. Like many doctors, Atri has no easy answers.

“It’s not a simple yes or no,” said the Banner Sun Health Research Institute neurologist in Arizona.

It probably won’t be for a while. Doctors across the country are still trying to figure out who should get the drug called Aduhelm, which at best slows down the deadly disease slightly. Other drugs for Alzheimer’s disease only temporarily relieve symptoms such as memory problems, insomnia, and depression.

While some clinics have already started giving the drug, many providers say it will be weeks or months before they are ready. Insurers – including the biggest bill payer for the drug, Medicare – have yet to determine which patients to cover for treatment that could cost more than $ 50,000 a year. And doctors fear that emotions will affect the decisions of patients and families in finding the drug.

“People are desperate. It’s a really horrible disease, ”said Dr. Michael Greicius of Stanford University.

Karl Newkirk hopes to start taking Aduhelm if his doctor agrees, as he sees no other treatment worth trying.

“It looks like the only star in the sky,” said an 80-year-old resident of Sarasota, Florida with early-stage Alzheimer’s disease.

Newkirk’s doctor confirms he is a good candidate for the drug. While the retired tech consultant is still fit enough to ride a roller coaster with his grandchildren in nearby Busch Gardens, he struggles with short-term memory loss. He wants to try Aduhelm, even though he is aware of the limits of the drug.

Michele Hall, 54, of Bradenton, Fla., Is also eager to discuss the drug during her next appointment with an Alzheimer’s specialist.

A former government lawyer, Hall had to quit her job after struggling with once-simple tasks like spelling, public speaking, and memorizing deadlines. She was diagnosed with early-onset Alzheimer’s disease last November by doctors at the Mayo Clinic.

Hall calls Aduhelm “the first little ray of hope” that she will spend more quality time with her husband and their three grown children.

“When you get this diagnosis, you really wake up every morning and say ‘Here I am, it’s moving on and I’m just waiting,’ she said. “Well, now you have something to look forward to. “

Biogen’s Aduhelm has been the first drug against Alzheimer’s disease for almost 20 years. Its approval by the Food and Drug Administration earlier this month sparked a swift reaction from many experts, including the agency’s own outside advisers who had warned that its supposed advantage was based on fragile data. Three resigned following the FDA’s decision.

Aduhelm does not reverse mental decline. It only slowed him down in one study that was marred by results that were difficult to interpret. The data was so obscure that the FDA ultimately granted conditional approval of the drug based on a different metric: its ability to get rid of harmful plaque build-ups in the brains of patients with early forms of the disease.

FDA approval is not limited to these early patients. Anyone with Alzheimer’s disease – at least in theory – could be prescribed the drug. But advocacy groups like the Alzheimer’s Association and many doctors say the focus should be on patients with early diagnosis, like those helped in the study.

“I don’t want to see people taking their mothers out of nursing homes to get this treatment,” said Dr. Babak Tousi, a Cleveland Clinic geriatrician who consulted Biogen and helped run one of the testing sites. for Aduhelm.

Safety will be a key consideration, according to Dr Ronald Petersen of the Mayo Clinic, which is developing its own guidelines for the use of the drug.

“We want to be conservative here,” said Petersen, an Alzheimer’s disease specialist who has consulted with most of the major drug makers in the field, including Biogen.

About 40% of patients receiving the full dose of the drug in Biogen studies had swelling or tiny bleeding in the brain. Although the side effects usually resolve themselves, in rare cases they have resulted in more severe bleeding that can potentially cause brain damage or other dangerous complications.

Monitoring of patients on medication involves regular brain scans. This is in addition to another type of analysis to determine if patients have the brain plaque targeted by the drug. Running all of those tests could easily approach $ 10,000 in the first year, doctors say.

Insurers will likely require prior approval for these tests, which could delay treatment. And depending on the coverage, patients could still be required to pay thousands of dollars per year for tests and treatments due to deductibles and other out-of-pocket expenses.

Biogen claims that approximately 900 sites in the United States have the equipment and expertise to immediately begin administering the drug, which requires monthly IVs.

The Michigan Private Institute for Neurological Disorders has already started treating patients with early-stage Alzheimer’s disease. The institute said it would bear most of the costs if an insurer ultimately refused coverage “because it’s therapy we believe in,” a spokeswoman said.

Meanwhile, Stanford’s Greicius, a neurologist and Alzheimer’s disease specialist, has no plans to prescribe Aduhelm.

“I don’t think there is enough evidence that it works, and there is a lot of evidence that it can harm patients,” he said.

He said he planned to present a “compelling and compassionate” case as to why he did not want to give the drug to patients. But he fears that some patients will simply turn to a doctor to provide it.

Tousi of the Cleveland Clinic said talking about expectations, costs and side effects could counter some emotional pressure to give the drug to patients who are not fit.

But part of the challenge is that family members often think that a patient is at an earlier stage of the disease than they actually are. He said they need to understand that the drug will not bring someone back to what they used to be.

“What we want cannot always be translated into real life,” he said.

A likely consequence of Aduhelm’s approval is earlier detection and diagnosis of Alzheimer’s disease, a long-standing goal of those studying the disease, given that it develops slowly over years or years. decades.

But earlier diagnosis combined with the added benefit of Aduhelm may simply prolong the difficulties of caring for someone with Alzheimer’s disease.

“It could turn out that it actually increases the burden on your caregiver if it slows things down a bit,” said Dr. Suzanne Schindler of Washington University in St. Louis. “I think it’s going to be really disappointing for a lot of people. “

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The Associated Press’s Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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