This has been a long running story, yet the FDA keeps funding usele$$ drugs to "cure" it
/
What’s the deal with Alzheimer’s disease and amyloid?
“For decades, scientists have concentrated on what now looks to be a blind alley.”
They focused on it because that’s where the money lay, but I’ve been reading reports of the flaws of the so-called plaque theory of the disease — many scientists were theorizing that the plaques were a symptom, not the cause — for at least a decade, but (your) money keeps rolling in.
Tiny excerpt here from a lengthy article explaining the problem:
Many scientists were outraged by the approval [A “disgraceful decision:” Researchers blast FDA for approving Alzheimer’s drug] Even the FDA’s own advisers and statisticians didn’t think the drug should be approved.and their outrage looked justified once we saw how the drug would be marketed: with a cognitive test that no one could pass. A congressional inquiry into aducanumab’s approval found it was “rife with irregularities.” But at $65,000 per patient per year, the drug represented a potential $18 billion-a-year revenue stream for Biogen.
Aducanumab was approved by the FDA in June 2021. But by early July, the regulator had already narrowed the set of people it would allow the drug to be given to, restricting it to just patients with a mild form of the disease. Biogen ended up losing money on it and removed the drug from the market in January 2024.
But only so it could concentrate on another amyloid-β-targeting antibody, this one developed with a biotech company called Eisai. This therapy, called lecanemab, was half the price of aducanumab, at $26,500 per year, and it got the nod from the FDA in 2023. There were plenty of questions about the approval because, yet again, there was very little data indicating that patients were getting any better. And there were still nasty side effects; three patients died from brain swelling and hemorrhaging.
Another antibody targeting amyloid-β, called donanemab, made headlines in 2023 when its maker, Eli Lilly, published trial data that claimed to slow the progression of the disease “by about 35 percent in the early stages.” Again, this came with the risk of severe side effects like brain swelling and bleeding. Those side effects may have been the only way to tell someone was on the drug, given that it provided extremely mild cognitive benefits.
>>>>
The Amyloid Mafia
We would almost certainly know a lot more about those other potential causes had it not been for the so-called Amyloid Mafia. Scientists aren’t immune to groupthink, and the people responsible for deciding who got research grants and who didn’t have not been at all receptive to proposals that investigate non-amyloid mechanisms.
“You were just lucky when you weren’t beaten up by the amyloid-β or tau people if you would mention immunology,” said Michael Heneka, a neuroinflammation specialist interviewed by Nature in 2023. (Tau is another Alzheimer ’s-associated protein.)
Speaking to American Public Media, the former director of Alzheimer’s research at the National Institute of Aging said, “It became gradually an infallible belief system. So everybody felt obligated to pay homage to the idea without questioning. And that’s not very healthy for science when scientists… accept an idea as infallible. That’s when you run into problems.”
To make matters worse, it turned out that much of that confidence in amyloid-β as the one true cause was built on fake data.
That landmark 2006 Nature paper that claimed to show that a specific form of amyloid-β was the culprit causing the disease? It was retracted in 2024 after it emerged that the authors had faked some of the data, copy-pasting images of protein detections. In another case, a scientist at City University of New York was indicted last year for falsifying data that helped support the ideas behind an Alzheimer’s drug being developed by Cassava Sciences. (For a more comprehensive look at the Amyloid Mafia, check out Charles Piller’s work.) Sadly, this kind of scientific misconduct is more common than we’d like and can be hard to detect before publication.
Those FDA drug approvals have also been tainted. In addition to the aforementioned congressional investigation that found irregularities, the head of FDA’s neuroscience office was forced to step down in 2023 after it was found that he had an inappropriately close relationship with Biogen.
Despite this litany of clinical failures and research misconduct, it would be a stretch to say that the amyloid hypothesis is dead. Only one of the five FDA-approved therapies is independent of the amyloid pathway, and while work is conducted on other areas, amyloid-β research remains the lion’s share.