New Alzheimer’s Drug Should Have Limited Use

Alzheimer’s community officials have expressed support for the FDA’s latest move, while medical professionals remain cautious about who they suggest the drug could benefit.

“It’s not far enough. They should really reconsider their decision and withdraw it from the market ”, Dr Lon Schneider, director of California Alzheimer’s Disease Center at the University of Southern California, told Healthline.

Schneider, who worked directly on the drug’s trials, said the research did not include people with diabetes or high blood pressure, or anyone taking blood thinners.

As the studies were truncated, he compared any endorsement of the drug to a baseball game.

“It’s like we’re having two baseball games and midway through the fifth inning you just called the winners,” said Schneider. “You don’t know what the real results might be. “

Dr. Paul E. Schulz, a neurologist at McGovern Medical School at UTHealth in Texas, told Healthline that he believes the FDA’s change is good and that his patients understand that the drug can only help people in the very early stages of disease.

“The new guidelines say it should be used specifically in patients with early-onset Alzheimer’s disease,” he said. “Most of the people who call us seem to get the idea that their loved one must be early in the process.”

“Withholding the drug from more advanced people is not meant to be cruel to those who have this misfortune,” he added. “It doesn’t make sense to give a drug with serious side effects to someone who probably won’t help.”

Schulz said that for medical professionals all eyes are on this Medicare review. He hopes this will guide them even further.

“None of us have inside information, but most of us think Medicare may choose to cover only those who fit the profile of patients who have participated in clinical trials for aducanumab,” he said. -he declares.

“So no matter what the FDA approves, it’s CMS [Centers for Medicare & Medicaid Services] who will decide who can actually get it. So in a sense, this move by the FDA brings its recommendations closer to what we think CMS will approve, ”added Schulz.

Alzheimer’s Association officials, who have advocated for drug approval, say they support the FDA change.

“The announcement was in line with the Alzheimer’s Association position that treatment should be initiated in patients at the stage of the disease studied in clinical trials – people with mild cognitive impairment (MCI) or stages of the disease. mild dementia of the disease, ”he added. Kristen cliffordthe association’s program manager told Healthline.

“We encourage people who are interested in learning more about this treatment, for themselves or for a loved one, to have a conversation with their health care provider,” she said.

And even with the limitations, Clifford said it still brings hope.

“This is the first approved treatment for Alzheimer’s disease since 2003, and the first to address the underlying biology of Alzheimer’s disease. This approval could mean more time for individuals to actively participate in daily life, have lasting independence and hold memories for longer, ”she said.

“We recognize that the drug may work differently for everyone who takes it and may not work for some people,” she added.

Dr Aaron S. Kesselheim, MPH, one of the FDA advisers who resigned following the initial decision, said he was happy to see the change but still hopes to see more.

“It is a useful and necessary step, but it is not enough, in part because numerous studies show that prescribers may not read the labeling of drugs in detail,” he told Healthline .

“The FDA needs to do a much better job of actively communicating the limits of the evidence on this drug’s benefits to combat the overly optimistic presentations that seem to be mushrooming online and elsewhere,” Kesselheim added.

Schulz hopes those seeking care remain hopeful despite the limitations.

“Most of the people who call us seem to get the idea that their loved one must be early in the process. Like us, they want us to have good drugs to try later in the illness. So they’re disappointed, but a lot of our good families are very realistic, ”he said.

“We haven’t been smart enough yet to find drugs that work later in the disease, but hopefully we will have some candidates someday,” Schulz added.