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Typically, the approval of a new drug designed to treat an otherwise untreatable condition would be cause for widespread celebration. That was not the case when the Food and Drug Administration approved aducanumab, a medication the agency called “the first therapy to target and affect the underlying disease process of Alzheimer’s.”
Alzheimer’s is a debilitating disease that affects more than 6 million Americans and was the seventh leading cause of death in the U.S. in 2020. The FDA’s approval of aducanumab last summer, though hailed by some Alzheimer’s advocacy groups, was met with intense criticism from some experts who raised questions about its effectiveness and potentially dangerous side effects.
At the core of the controversy over aducanumab is a broader debate over what causes Alzheimer’s disease and how it might one day be treated. The drug, which is sold under the brand name Aduhelm, targets a protein called amyloid that builds up as plaque in the brain of Alzheimer’s patients. Some neuroscientists believe that clearing this plaque could be the key to, if not curing Alzheimer’s, at least slowing its progression. A trial of aducanumab showed that it helps reduce amyloid plaque. It did not, however, provide any evidence that the drug slows or reverses cognitive decline caused by Alzheimer’s.
After reviewing the results of the trial, an independent panel of scientists overwhelmingly advised the FDA not to approve the drug. The agency ignored the recommendation, prompting three members of the panel to resign in protest. Criticism of the FDA’s decision intensified when Biogen, the company that developed aducanumab, set a price of $56,000 for an annual course of treatment. That price was cut in half by the company last month.
The latest twist in the ongoing saga came earlier this month when the agency that runs Medicare announced it would only cover the cost of the Aduhelm for patients involved in clinical trials designed to further test its effectiveness. Most Alzheimer’s patients are old enough to qualify for Medicare, meaning that that decision is likely to dramatically reduce the number of people who will be able to access the drug.
Why there’s debate
Two of the biggest Alzheimer’s patient advocacy groups have heavily criticized the decision to limit Medicare’s coverage of Aduhelm. In a statement to the New York Times, the head of the Alzheimer’s Association called the move “shocking discrimination against everyone with Alzheimer’s disease.”
“This is just not a tolerable situation,” the co-founder of UsAgainstAlzheimer’s told Politico.
The main argument put forth by patient advocacy groups, and often echoed by some doctors who treat Alzheimer’s patients, is that there is enough promise in the amyloid theory to justify full approval of Aduhelm. They add that restricting its use will mean denying countless people access to what is currently the only treatment that shows any real hope of curbing Alzheimer’s.
But skeptics say it is irresponsible to give patients a drug that has shown no ability to actually limit the impacts of Alzheimer’s, especially when it may cause serious side effects like swelling or bleeding in the brain. It would be even more inexcusable, they say, to ask a taxpayer-funded program to cover what they see as the exorbitant costs of a drug that isn’t proven to work.
Some patient groups also argue that the focus on a pharmaceutical solution to Alzheimer’s draws attention and resources away from the everyday support systems that people with the condition need to get by.
Medicare’s decision to limit coverage for Aduhelm won’t be finalized until the spring, after a required public comment period on the issue has been completed. The pharmaceutical giant Eli Lilly is expected to submit its own anti-amyloid drug for approval within the next few months, with a decision from the FDA anticipated before the end of the year.
Aduhelm may not be the cure, but it’s a step in the right direction
“The first cell phone was expensive and didn’t work very well; it nonetheless changed the world. Just so, I foresee Aduhelm doing some direct good, but also stimulating more research, and more and better treatments.” — James I. Mangi, Detroit Free Press
Drugs should be judged on how what they can do, not what they might do
“Physicians and hospitals should also stand together and agree to only provide aducanumab in the context of a new trial designed with endpoints that are clinically meaningful — namely, slowing the progression of Alzheimer's disease.” — Reshma Ramachandran and Joseph S. Ross, CNN
Even if Aduhelm only offers small benefits, it’s worth the investment
“Alzheimer’s and other types of dementia are expected to cost the nation $355 billion this year. If Aduhelm delays the progression of the disease for some patients even by a year or two, it will save tens of billions of dollars in Medicaid, home care and other health costs.” — Editorial, Wall Street Journal
The only thing that’s certain about Aduhelm is it causes dangerous side effects
“This is not a cure. The disease will continue and perhaps the best-case scenario is that someone will get a modest improvement in their cognition. But it's not going to stop the disease from progressing. … What's not in question is the fact that it can cause cerebral hemorrhage and swelling in a significant number of patients.” — Zaldy Tan, memory and aging specialist, to NPR
It may never be clear whether Aduhelm actually works
“Though patients will start taking it, if the past is any guide, the world may have to wait many years to find out whether Aduhelm is actually effective — and may never know for sure.” — Elisabeth Rosenthal, Washington Post
Support, not the pursuit of a miracle drug, is what Alzheimer’s patients need most
“We need to break the absurdity of embracing a pharmaceutical stimulus package for care. We need a new approach to Alzheimer’s and all other diseases that cause dementia. We do need effective drug treatments. But short of cures, patients need services and supports. Simply put, we’re not going to drug our way out of our despair.” — Jason Karlawish, Philadelphia Inquirer
Aduhelm’s approval provides hope that drugs for other neurological disorders may soon become available
“I’m always looking at a glass half full. I hope that this will soften the FDA when they review drugs for other diseases.” — Joseph Jankovic, neurologist, to Nature
Aduhelm highlights the corruption of the pharmaceutical industry
“The aducanumab debacle is a microcosm of how the medical-industrial complex has taken hold within the Alzheimer’s field for decades, distorting science and policy while limiting other promising avenues of research and action on brain health and the care of persons living with dementia.” — Daniel R. George and Peter J. Whitehouse, Scientific American
Aduhelm may prove to be the cure, but the FDA can’t make decisions based on hope
“It is possible that when mildly impaired patients are treated for five years or 10 years or more with Aduhelm, a meaningful clinical benefit will be obvious. I hope this will occur. But FDA approvals should be based on data, not speculation.” — Sam Gandy, Stat
Big pharma pursuit of profit is holding back progress on meaningful treatments
“It’s hard not to connect large donations from Biogen and other pharmaceutical companies to the laserlike focus that Alzheimer’s groups have on drug-based approaches. … The predominant industry emphasis on amyloid plaque as the cause of Alzheimer’s disease has restricted research on any theories or therapies that do not focus on amyloid.” — David Stanke and Adriane Fugh-Berman, Chicago Tribune
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Making sense of controversy over the new Alzheimer’s drug – Yahoo News
“The 360” shows you diverse perspectives on the day’s top stories and debates.