Is Biogen’s new Alzheimer’s drug a groundbreaking treatment – or the FDA’s BIGGEST MISTAKE?

Biogen’s Aducanumab (shelf name: Aduhelm) is the first Alzheimer’s drug to be approved by the FDA in 20 years.

TWENTY. YEARS.

At the time of its approval, many (including myself) expected the news to be greeted with celebration – perhaps a small victory against a truly devastating disease that affects over 6 million Americans today.

Instead of celebration, however, the FDA was met with a firestorm and then there were the string of resignations at the FDA’s 11-member independent advisory panel.

Not a single member of the FDA’s independent panel voted in favour of approving Biogen’s new treatment for Alzheimer’s. Nine voted against and two members abstained.

One of the panel’s key members, Dr Aaron Kasselheim, went on later to write that the FDA’s approval of Aducanumab was the “worst drug approval decision in recent U.S. history.”

Aducanumab acts through targeting (and breaking down) beta amyloid plaques in the brain. These are the same plaques that are believed to be responsible for much of the cognitive decline observed in Alzheimer’s.

And while there is substantial evidence dating back to (at least) 2016 that Aducanumab does indeed break down these amyloid plaques – there is little evidence that this will translate into slowing down cognitive decline in Alzheimer’s patients.

In fact, Biogen has failed to demonstrate Aducanumab’s efficacy in several clinical trials.

There have been (in the past) several drugs that were able to clear beta amyloid plaques from the brain. None of these drugs, however, were able to illustrate cognitive improvements in clinical trials.

Aducanumab’s fate could very well turn out to be the same – despite having been approved, there is little evidence (thus far) Aducanumab will help patients.

And research scientists have other cause for concern. Biogen’s Aduhelm may, in fact, be too “unsafe” – 42% of patients in one clinical trial experienced brain swelling or a brain bleed shortly after taking their first dose of the drug.

This seems to largely agree with what Biogen itself stated about its new treatment – that it could potentially take another nine years to confirm whether removing amyloid really slows the “ravages” of the fatal mind-wasting disease that is Alzheimer’s.

Prevalence.

Alzheimer’s is ranked as the sixth leading cause of death in the United States and Alzheimer’s deaths are only expected to increase as the world population continues to age dramatically in the next 20–40 years.

Dementia is costing us economically too. Dementia cost “the world” an estimated USD 800 billion in 2015 alone – or 1.1% of global GDP. Despite heavy investments in promising new drugs, the vast majority of these endeavours have thus far turned out fruitless.

And so the FDA disregarded the opinion of its independent advisory panel and experts in the field; approving Aduhelm under the “Accelerated Approval Pathway.” The “AAP” OKs drugs that fill unmet medical needs, however, it does not guarantee that these drugs are likely to have clinical benefits.

So.. Desperation I Guess..?

Did the FDA jump the gun? I’d like to hear your thoughts.

Personally, I think it’s high time we revisit the idea that beta amyloid plaques in the brain are the root cause of the cognitive impairment observed in Alzheimer’s. Some scientists have already pointed out that there may be other (perhaps, more obvious) disease models (and hence, treatment approaches) that we’re failing to see because of our collective “obsession” with the beta amyloid plaque theory..

So is it time to move on..?

I’m Hesham and I’m a University of Cambridge graduate and Student Doctor. I also run a medical/health YouTube channel where I explain the science behind how you can live a longer and healthier life.

If you enjoyed this article, then chances are you’ll enjoy my YouTube videos even more!

N.B. In a statement, the FDA said it anticipated “an expectation of clinical benefit,” from the drug’s approval, and that it believed that “the benefits [of aducanumab] for patients with Alzheimer’s disease outweighed the risks of the therapy.” The FDA also said it would require the manufacturer, Biogen, to conduct further clinical trials to verify the drug’s safety and efficacy, and could remove it from the market if it proves ineffective.

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Hesham Mashhour

Cambridge Graduate. I write about #health #medicine and will occasionally share my thoughts about the latest #music and trash coming out of #Netflix