FDA approves Alzheimer’s drug Aducanumab in controversial decision



Because I happen to have a particularly mean dog in this fight, I’ve been following the controversy surrounding Biogen’s new treatment for Alzheimer’s disease closely and, to be frank, I’m not too happy. of the people involved. Of The New Yorker:

Last week, in what should have been really exciting news, the Food and Drug Administration approved aducanumab, the first new drug in nearly twenty years designed to treat patients with Alzheimer’s disease. But in doing so, the agency ignored the overwhelmingly negative recommendation of the Central and Peripheral Nervous System Drugs Advisory Committee, none of whose members found sufficient evidence that the drug could slow the cognitive decline characteristic of the disease. dementia. Ten members voted against approval; one voted “uncertain”. Another member abstained because he had been an investigator in one of the drug’s two major trials.

By the end of the week, three of the committee members had resigned and many experts suggested that the new drug, which Biogen will market as Aduhelm, may cause more problems than it solves, at the same time. both for people with Alzheimer’s and for the health of the nation. -system of care. “This may be the worst FDA approval decision I can remember,” Aaron Kesselheim, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, told The Times.

I’m not denying that society and the medical community have made great strides since 1985 when my father was first diagnosed with AD. He had gone out to buy flowers for the family plots on Remembrance Day and found himself two days later in Vermont. When we contacted Massachusetts State Police, an officer suggested that “Sometimes older gentlemen run away with secretaries.” There was no medical intervention available at the time. My father completely stopped talking two years before he died.

By the time the disease spread to her sister in 2004, the Wanderers program was in place, and every cop around would have thought “Alzheimer’s” upon hearing of the disappearance of an elderly citizen. My aunt was able to tolerate Aricept and was able to converse until the night of her death. The conversations were repetitive and all concerned events in the distant past, but they were conversations. You pray for these little miracles.

Now comes Biogen and Aduheim, which Biogen will market at the low and low prescription price of $ 56,000 per year. It’s given intravenously, and as anyone familiar with Alzheimer’s patients will tell you, having them sit quietly in a chair for an hour while a stranger pushes and pushes them is a guaranteed adventure. But the real dog in the nursery here is whether or not the drug does what it’s supposed to do, and that leads him to one of the oldest and most passionate arguments in D’s disease research. ‘Alzheimer’s.

In the brain of every patient with Alzheimer’s disease are plaques of a gummy protein called beta-amyloid. It is the opinion of many, if not most, Alzheimer’s disease researchers that it is these plaques that cause the progressive loss of cognitive function that is the hallmark of the disease. However, there is another lingering school of thought that argues that while plaques may be markers of disease progression, they are not the causative agents of its devastating symptoms. In short, this faction of researchers argues that reducing plaque does not slow disease. This is where the new drug goes into the maelstrom.

Scientists consider these plaques to be clear biomarkers of Alzheimer’s disease, and they have been trying for decades to show that reducing these levels of amyloid could help patients regain their cognitive abilities, or at least stop them. decline. None of the drugs in these previous studies had any impact on the course of the disease.

The two clinical trials that led the FDA to approve aducanumab served the same indirect goal: to show the drug’s ability to reduce the plaques that build up in the brain. But the initial data on slowing patients’ cognitive decline was so poor that in 2019, the company halted the studies. It was only after the researchers at Biogen, in consultation with the FDA, re-examined the data later in the year and included more than three hundred additional participants who completed the studies after the initial data evaluation. that they noticed something that they considered to be promising… Nevertheless, instead of evaluating this drug only to determine if it affects cognition, the FDA granted conditional approval based on the ability of aducanumab to reduce these amyloid plaques.

The FDA just has to do better than that. Sometimes expedited approvals are required; they worked during the early days of AIDS therapy. But it has all the hallmarks of a really terrible mistake. And for Biogen to charge $ 56,000 a year for the treatment, defrauding an elderly population, most of whom are on Medicare, or who have no health insurance at all, is unreasonable. I’m not happy with any of those people.

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