Corrupt FDA?

[BoSoxGal]

This headline reminded me of a story I would’ve posted here if not for being on sabbatical. It’s a story that I find heartbreaking as an almost Greek tragedy level depiction of human frailty in the many manifestations.

FDA is now calling for an independent agency review of its relationship with hometown biotechnology company Biogen, regarding particularly the recent FDA approval of Aduhelm, the first new Alzheimer’s pharmaceutical treatment in 20 years.

Quick recap, several research scientists and clinicians on the advisory board for Biogen’s Aduhelm resigned in protest recently when FDA approved the drug, because all the data show that there is no real evidence it works, it costs $56,000/year per patient and requires the additional cost of routine regular MRIs, to monitor for the very serious side effects of brain swelling or bleeding that are the primary risk of Aduhelm therapy. Additionally, the drug was only really meant for very early stage dementia, yet FDA approved it for ALL Alzheimer’s patients - creating an instant massive market for this dud drug.

Consider the potential for selling the hope of this very expensive therapy to millions of families losing a loved one to the horrors of Alzheimer’s. I can almost imagine the hideous TV/online advertising campaign in my mind’s eye.

Then imagine how quickly many millions of people demanding and taking this largely useless pharmaceutical therapy, with added expensive testing requirements, and costs to treat the high risk side effects, will drain Medicare and Medicaid. Never mind the disincentive to actually find a drug that works when a lucrative snake oil is setting fire the marketplace.

This is a story to watch.

I can’t help but think somebody got a payday. And doesn’t this just make the FDA look great when already tens of millions of Americans are questioning the speedy approval of covid19 vaccines? Way to play into the conspiracy theories, FDA employees on the take/incompetent.

Having spent half a decade now caring for folks with Alzheimer’s and related dementia, and seeing the toll it takes on families and friends when they lose a person to cognitive decline, I’m just outraged anyone would try to peddle snake oil to them. I would like to believe most of the team at Biogen is well intended, but science just is and data just is, and there is very little excuse for ignoring results - so it must all come down to greed.


Acting FDA commissioner calls for independent investigation into approval of Alzheimer's drug


Here’s the NYT piece discussing the advisory resignations from a month ago: Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug

The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients.

[Burning Petard]

No need for bribery--this is an example of the life cycle of federal regulatory agencies. They start as a way to throttle bad behavior by some or many in an industry--to act for the public. But the public does not pay, in any direct way, to the functioning of the agency. The industry pays for lobbyists and makes direct payment to congress critters. Eventually the agency morphs into acting to protect and foster the industry. The Federal Consumer Protection Agency is a prime example of just how swiftly this process can develop. In this case, the FDA acted just a bit too blatantly.

Why do you think your bottle of Vitamin C tablets is made without FDA oversight?

snailgate.

[ex-khobar Andy]

Maybe there's a clue here? Biogen stock price:



Guess what happened a few days into June.

[BoSoxGal]

Here is a good piece about how Biogen’s Aduhelm will hurt ALL seniors and drain Medicare/Medicaid.

How everyone on Medicare could end up paying for the pricey new Alzheimer's drug


I’m fantasizing about fire bombing the luxury automobiles, mansions and yachts of Biogen’s senior management team.