FDA gives full, traditional approval for Leqembi

With the uncertainties in safety and efficacy of these immunotherapies, the approval of Leqembi is likely to issue in a concerning era of future drug approvals.

In a not too surprising turn of events the FDA has granted full, traditional approval for Leqembi for use against Alzheimer’s Disease.

Leqembi is an immunotherapy intent on targeting the amyloid plaques that may form during disease progression. It’s been argued that this approach may limit the progression of the disease and buy more time with more mild cognitive loss.

However, for anyone who has been reading this Substack in the past few months, you would know that I have raised serious concerns over these immunotherapies as they tend to show moderate slowing of Alzheimer’s while also coming with serious side effects such as brain bleeding and hemorrhages.

As all of this has been hammered out before, I’ll point to prior posts for those interested:

FDA grants accelerated approval for Lecanemab (Leqembi), even after the multitude of controversies hitting both the FDA and Biogen

Leqembi is likely to see full, traditional FDA approval. But can anyone explain what it actually does?

What exactly is "clinically meaningful" when it comes to Leqembi?

Seeking Leqembi's approval at all costs

My primary point of concern is that these drugs serve as pathways for the new era of accelerated approval, which relies on the hopes and wants of the public for pharmaceutical companies to provide them with some treatment for modern maladies such as Alzheimer’s Disease, obesity, or cardiovascular disease.

By weaponizing the public’s want Big Pharma can push through any drug using limited clinical data while also silencing any dissenting viewpoints. Just rile up the masses and prevent any contrasting voices from being heard.

But in the case of Leqembi, the approval marks a deeper concern over scientific dogma.

For years, Alzheimer’s research has been plagued with controversies surrounding the amyloid hypothesis which has become dogma in this field. The hypothesis suggests that amyloid plaques and other misfolded proteins are closely associated with the progression of the disease, and thus research endeavors have looked predominately at finding ways to remove these plaques and proteins. This has led funding and the scientific discourse surrounding Alzheimer’s to focus solely on this hypothesis.

Anyone who appears to dissent or raise criticisms of this hypothesis is likely to be shut down, and even have their funding removed for not going along.

An excerpt from a previously cited Science article has this to say in regards to this amyloid hypothesis (emphasis mine):

One of its biggest mysteries is also its most distinctive feature: the plaques and other protein deposits that German pathologist Alois Alzheimer linked to the disease in 1906. In 1984, Aβ was identified as the main component of the plaques. And in 1991, researchers traced family-linked Alzheimer’s to mutations in the gene for a precursor protein from which amyloid derives. To many scientists, it seemed clear that Aβ buildup sets off a cascade of damage and dysfunction in neurons, causing dementia. Stopping amyloid deposits became the most plausible therapeutic strategy.

Hundreds of clinical trials of amyloid-targeted therapies have yielded few glimmers of promise, however; only the underwhelming Aduhelm has gained FDA approval. Yet Aβ still dominates research and drug development. NIH spent about $1.6 billion on projects that mention amyloids in this fiscal year, about half its overall Alzheimer’s funding. Scientists who advance other potential Alzheimer’s causes, such as immune dysfunction or inflammation, complain they have been sidelined by the “amyloid mafia.” Forsayeth says the amyloid hypothesis became “the scientific equivalent of the Ptolemaic model of the Solar System,” in which the Sun and planets rotate around Earth.

By 2006, the centenary of Alois Alzheimer’s epic discovery, a growing cadre of skeptics wondered aloud whether the field needed a reset. Then, a breathtaking Nature paper entered the breach.

The paper in question that seems to have led scientists down the path of the amyloid hypothesis has come under scrutiny for possibly falsifying data and served as one of the main concerns in the Science article. And yet, that Nature paper was cited thousands of times in the literature, and essentially affirmed the amyloid hypothesis above any other alternative explanation. It essentially validated this hypothesis, ossifying it and preventing any other ideas from gaining traction:

The paper provided an “important boost” to the amyloid and toxic oligomer hypotheses when they faced rising doubts, Südhof says. “Proponents loved it, because it seemed to be an independent validation of what they have been proposing for a long time.”

“That was a really big finding that kind of turned the field on its head,” partly because of Ashe’s impeccable imprimatur, Wilcock says. “It drove a lot of other investigators to … go looking for these [heavier] oligomer species.”

So this approval has done even more harm to the field of science by further ossifying this controversial hypothesis. It now sends a signal to both scientists and Big Pharma that this is the path to take for treating Alzheimer’s because you are likely to gain funding and approval, even if doctors and patients alike can’t describe what benefits they should see from the drug, which comes with serious adverse reactions.

This is again a process of validation through authorization. It doesn’t matter if the drug may not work or may actually be harmful. Because it has been approved it has to show some benefit, otherwise it wouldn’t be approved, right?

Note that this type of language even appears in the FDA press release:

“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”

And so, this is likely to serve as a concerning indication for what’s to come with drug approvals in the future.

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