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The FDA disregards the advice of its own experts and approves a potentially dangerous/ineffective Alzheimer's treatment that costs $56,000/year


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This decision by the FDA just appears to be shockingly irresponsible.

 

"A “disgraceful decision:” Researchers blast FDA for approving Alzheimer’s drug | Ars Technica"

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ARSTECHNICA.COM

Even the FDA's own advisers and statisticians didn't think the drug should be approved.

 

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Pharma conspiracy theorists always assume companies have working cures hidden away because they want to keep people sick. This is ignorance of how the drug market and research work. We should be MUCH more wary of this… approvals with dubious evidence. 

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It’s the same bullshit nonsense.  People act like natural cures are everywhere but unprofitable which ignores the fact that billions of doses of aspirin are sold and that “natural” supplements are sold at the store for a shit load of money.

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This drug wasn’t or hasn’t been approved in Canada but my local Toronto news station interviewed a lady who got in on the trial in Canada. From the emotions of the husband to seeing his wife recognize his name and face again was something to see. I’m sure they have the cure for most diseases but the profit margins and new customers being born everyday. Why bother giving up the golden goose right. 
 

 

they also did this on Family Guy with Lois father dying of cancer but his company had the cure for it ten entire time. He got better and released a bullshit product after he got better for consumers instead

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They recommended another trial, but who's going to risk a 50-50 on getting a placebo when they can just get a prescription for it? And they massively jacked up the price, which is going to cost us all money one way or another (e.g. increased insurance premiums) despite the fact that it may just be snake oil.

 

What a clusterfuck.

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21 minutes ago, Jason said:

They recommended another trial, but who's going to risk a 50-50 on getting a placebo when they can just get a prescription for it? And they massively jacked up the price, which is going to cost us all money one way or another (e.g. increased insurance premiums) despite the fact that it may just be snake oil.

 

What a clusterfuck.

 

Recommending additional trials upon approval isn’t inherently problematic, it happens pretty regularly. It’s just normally stuff like, “it seems like there might be a different side effect profile in this cohort that warrants further research,” and not… this.

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26 minutes ago, Jason said:

They recommended another trial, but who's going to risk a 50-50 on getting a placebo when they can just get a prescription for it? And they massively jacked up the price, which is going to cost us all money one way or another (e.g. increased insurance premiums) despite the fact that it may just be snake oil.

 

What a clusterfuck.

 

The answer to 'who will risk it' is: nearly every family that has a loved one with Alzheimer's. 

 

My family dealt with this for years as my grandmother's dementia progressed. Being on that side of the issue, I can't really tell if this is exploitative of families that deal with dementia (because they WILL take the chance on the coin flip if they can), or if it's just something better than whatever else is out there that they've tried to no effect. 

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Just now, CayceG said:

The answer to 'who will risk it' is: nearly every family that has a loved one with Alzheimer's. 

 

I'm not sure I'm following how your response relates to what I said. If you can get a prescription and be 100% sure you're not just getting the sugar pill then why would you register for the trial and accept the 50% chance of getting the sugar pill?

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5 minutes ago, Jason said:

 

I'm not sure I'm following how your response relates to what I said. If you can get a prescription and be 100% sure you're not just getting the sugar pill then why would you register for the trial and accept the 50% chance of getting the sugar pill?


Because it’s free?

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6 minutes ago, Jason said:

 

I'm not sure I'm following how your response relates to what I said. If you can get a prescription and be 100% sure you're not just getting the sugar pill then why would you register for the trial and accept the 50% chance of getting the sugar pill?

 

Probably because the trial would be free, while you'd have to pay for the prescription (at least some amount).

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2 minutes ago, Jason said:

 

I'm not sure I'm following how your response relates to what I said. If you can get a prescription and be 100% sure you're not just getting the sugar pill then why would you register for the trial and accept the 50% chance of getting the sugar pill?


I would take whatever hope possible that big pharma could offer me. I too know of family/friends with family who have gone through this, or is dealing with this ordeal and I think they too would take whatever hope offered as well. 

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Two neurologists have resigned from the FDA advisory panel over this.

 

"Doctors Resign From FDA Panel After Aducanumab Approval"

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WWW.BUSINESSINSIDER.COM

The advisory panel voted in November that the FDA shouldn't approve the drug, called Aduhelm.
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1 hour ago, Joe said:

Because it’s free?

 

1 hour ago, CitizenVectron said:

 

Probably because the trial would be free, while you'd have to pay for the prescription (at least some amount).

 

I guess, but new expensive drugs usually have copay assistance programs, at least for people with insurance. They don't expect people to actually be able to pay to their portion of the astronomical prices of these, they just want to milk the insurance companies.

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A third member of the FDA’s advisory board has resigned over this decision.

 

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WWW.CNBC.COM

A third member of a key FDA panel has resigned over the agency's controversial decision to approve Biogen's new Alzheimer's drug, Aduhelm, CNBC has learned.

 

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$56k? That's it? Biogen getting soft. 

 

Having gone down the road of rare disease medication twice, the FDA is only the first stop for commercial approval, next is insurance and I'd be surprised if they don't lock this behind a ton of quantitative requirements to show individual improvement or get cut off. 

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