re: 3 experts resign from FDA over drug approval debacle

The argument here is over what constitutes "efficacy". The advisory board doesn't want to accept b-amyloid clearance and is insisting on cognitive maintenance or improvements.

This, in my opinion, is unfair to the company because these same scientists have argued for years that b-amyloid deposition is the driver of AD. Now this advisory board is not accepting that removing it is evidence of clinical benefit.

And they might be right, but this same group of "experts" has no data to indicate that plaque clearance will not improve cognitive function. Getting that data would take several more years given that AD is a slowly progressing disease in the vast majority of patients. So demanding that data means a potentially beneficial drug is kept from patients for another 3-4 years...even though it is known to clear plaques...the main driver of the cognitive decline.


I'm also a little puzzled at "this board's" response. This is the same FDA that wouldn't sign-off on hydroxychloroquine in a cocktail thought to prevent or reduce symptoms associated with CV19. It bitched then that the FDA wouldn't approve. Now it bitches that it will approve an AD drug with established efficacy data on plaque clearance.

And why do you have any faith in this advisory board?
They are just scientists...just like the scientists that told you HQX wasn't effective for CV19 and that the Wuhan lab leak was a conspiracy theory.

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Now, why would the FDA go against their expert reviewers to approve a drug? $$$$$$$$$$$$$

Is this shite starting to sink in yet, people?

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See the NAC thread. What Pharma wants, Pharma gets!

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Yeah supposedly the drug has very little data to support its use but comes at a high cost to insurance companies. The worst kind of drug.

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Actually, it won't be a problem for the insurance companies as they can do what they frequently do w/ an expensive drug: deny payment. The insurance companies can always find a way to avoid paying for a drug is they really want to. As usual, the one who suffers will be the patient or family if they end up doing what's frequently done when a treatment isn't covered by the insurance: pay for it out of pocket.

If you are against this drug’s approval you are against science.

That’s interesting... on a side note... someone a heart transplant list was looking into stem cell implants only available in Germany...

My brother had pancreatic cancer and tried everything available but was not able to travel in the sixth months he had left.

Desperate times call for desperate measures

Serious question how do you actually know this will not provide a benefit?

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Nevertheless, the FDA approved the drug on Monday. Though the regulator acknowledged that there are “residual uncertainties regarding [the] clinical benefit” of Aduhelm, the FDA said it decided to lower the requirements for approval after the advisory committee voted.

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Why have the FDA at all if they have no standards?

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Why have the FDA at all if they have no standards?

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These definitions are semi arbitrary and set by the FDA. Technically, they can change them at any time

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Thanks.

Regulatory capture is nothing new. Been around since forever. It's gotten particularly bad in recent years but that's to be expected as Society continues to degrade. The dangerous part is that people still trust these Regulatory Agencies and their stamps of approval but that trust is based on past reputation built on integrity that no longer exists.

This is why I don't trust our food or our medicine. The shite you put in your body. The shite you are built on. Big Agri or Big Pharma. And people think I'm a liberal hippie because I try to only give my kids organic or locally-sourced food and they think I'm a right-wing conspiracy theorist because no one in my family eats any prescription pills of any kind for any reason and I won't get my kids vaccinated.