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Old 06-07-2021, 12:06 PM
 
23,179 posts, read 14,548,136 times
Reputation: 37043

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I was pretty shocked to be honest that the FDA approved this drug, considering the FDA advisory panel was against approval. I'm happy they did of course since there are no drugs like this currently available to treat Alzheimer sufferers. It may not have been a slam dunk statistically (or even close to showing definitive proof of some efficacy), but when patients have no other options and can potentially add a few extra years of quality of life, why not.

https://www.yahoo.com/news/u-fda-set...100631773.html

Quote:
U.S. regulators on Monday approved Biogen Inc's aducanumab as the first treatment to attack a likely cause of Alzheimer's disease, sending its shares soaring, despite controversy over whether the clinical evidence proves the drug works.

Biogen said it has priced the drug, to be sold as Aduhelm, at $56,000 per year. Its shares jumped nearly 52% to $434.52 when trading resumed following the approval. U.S. traded shares of partner Eisai Co were already up $33.50, or 45%, to $107.75

Aducanumab aims to remove sticky deposits of a protein called amyloid beta from the brains of patients in earlier stages of Alzheimer's in order to stave off its ravages, which include memory loss and the inability to care for one's self.

"This is good news for patients with Alzheimer's disease. We've not had a disease modifying therapy approved ever," said Dr. Ronald Petersen, an Alzheimer's disease expert at the Mayo Clinic. However, he cautioned, "This is not a cure. It's hoped that this will slow the progression of the disease."

"It think this is a big day," Dr. Peterson said. "But we can't overpromise."

Alzheimer's is the sixth leading cause of death in the United States.
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Old 06-07-2021, 04:31 PM
 
1,627 posts, read 599,392 times
Reputation: 2802
Why not? Because the benefits remain unproven and the data suggests that if and when they are proven, they will be very slight. At the same time, the treatment has relatively common severe adverse side effects (like brain swelling), and is incredibly expensive.

I doubt the benefits involve “adding a few years of quality life.”
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Old 06-07-2021, 08:10 PM
 
14 posts, read 3,232 times
Reputation: 60
It doesn't even work, but that didn't stop them from approving it. And once the next trial is done, if there is no benefit, they STILL don't have to pull it.

Money grubbing.
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Old 06-08-2021, 08:42 PM
 
Location: Newburyport, MA
5,060 posts, read 2,456,425 times
Reputation: 6159
I have worked in drug research for over 20 years. This is a highly unusual approval, and I think it's a big mistake. Multiple other drugs have tried the same mechanism, and they failed to show improvements in patient memory or cognition, even if they reduced amyloid beta deposits. This drug, has arguably failed to show improvements in patient memory or cognition, consistent with the earlier attempts, which is all the more reason to consider the weak evidence for efficacy here suspect.

The FDA's independent expert panel on this project - they always use one, not a single person on that panel voted to approve Aduhelm. Yet the FDA still granted approval. Now, mind you, the FDA has acknowledged that the evidence is weak, and are requiring Biogen to do a (unusual) Phase IV trial after approval to gather further evidence. But why you'd approve this at all, isn't clear to me. Maybe, possibly, might work has never been good enough before. They shouldn't begin accepting that now.
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Old 06-09-2021, 04:14 AM
 
Location: San Antonio/Houston-Dallas/Tricity
46,541 posts, read 66,782,988 times
Reputation: 107285
It will be a new big $$$$ maker. I can see the doctors pushing it for profit.
The approval is, without a doubt, a landmark. It could provide hope to millions of patients, who currently have few options. And, given those limited options, it will certainly provide a massive money-maker for its developer, Biogen, which has already set the list price for a year’s worth of Aduhelm at $56,000. Analysists estimate that the drug will bring in $5 billion to $6 billion worth of sales per year in the US alone.
In addition, there will most likely be tens of thousands of dollars in costs for diagnostic testing and brain imaging.

The Institute for Clinical and Economic Review had recommended a price point of between $2,500 to $8,300 to be considered cost-effective. This price also took into the account the “insufficient” evidence regarding Aduhelm’s benefits.

The most common side effects of aducanumab were ARIA, headache, fall, diarrhea, and confusion/delirium/altered mental status/disorientation
Since the injection is recommended to those with MILD symptoms, the COMMON side effects will greatly deteriorate their cognitive functions.

FDA - useless, and greedy as always.
https://www.pogo.org/investigation/2...ings-attached/

On average, about 4,500 drugs and devices are pulled from U.S. shelves each year. The recalled products have U.S. Food and Drug Administration (FDA) approval and in many cases, are widely ingested, injected or implanted before being recalled.
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Last edited by elnina; 06-09-2021 at 04:50 AM..
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Old 06-09-2021, 05:19 AM
 
7,214 posts, read 3,529,278 times
Reputation: 13742
Quote:
Originally Posted by OutdoorLover View Post
I have worked in drug research for over 20 years. This is a highly unusual approval, and I think it's a big mistake. Multiple other drugs have tried the same mechanism, and they failed to show improvements in patient memory or cognition, even if they reduced amyloid beta deposits. This drug, has arguably failed to show improvements in patient memory or cognition, consistent with the earlier attempts, which is all the more reason to consider the weak evidence for efficacy here suspect.

The FDA's independent expert panel on this project - they always use one, not a single person on that panel voted to approve Aduhelm. Yet the FDA still granted approval. Now, mind you, the FDA has acknowledged that the evidence is weak, and are requiring Biogen to do a (unusual) Phase IV trial after approval to gather further evidence. But why you'd approve this at all, isn't clear to me. Maybe, possibly, might work has never been good enough before. They shouldn't begin accepting that now.
I assume they want a bigger sample size. That said, I am not sure how popular it will be if it doesn’t really work and is expensive. Is Medicare part D going to pay for this?
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Old 06-09-2021, 08:57 AM
 
3,419 posts, read 1,830,781 times
Reputation: 6635
Oh Great. Here comes yet another Pharma Commercial showing shiny happy people living life to the fullest while some woman with a pleasant voice mumbles about deadly side effects interrupting my nightly pleasure of Green Acres.
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Old 06-09-2021, 09:38 AM
 
Location: Early America
2,456 posts, read 1,303,359 times
Reputation: 5924
Biogen was facing bankruptcy if this drug wasn't approved. That is what this is about. It's good for business, but bad for science and patients.
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Old 06-09-2021, 11:32 AM
 
Location: On the wind
1,133 posts, read 564,590 times
Reputation: 2444
People who are desperate will try anything, even if the result is not 100% or even close to that.
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Old 06-09-2021, 01:55 PM
 
Location: Newburyport, MA
5,060 posts, read 2,456,425 times
Reputation: 6159
For what it's worth, neither doctors nor the FDA make any money when drugs are sold. Biogen though, yes, stands to make a lot of money. I think the approval is a mistake as stated earlier, but if you'd ask me to guess why - I think it's because Alzheimer's is a serious and growing problem, and we really don't have any good options yet, despite decades of attempts, plus, patient advocacy groups have been clamoring for the FDA to approve something - and they have been celebrating the approval, the attitude there seems to be we've got nothing now and this disease is awful, so just give us something. So I think this may just be the FDA yielding to that patient group pressure and taking a chance that there may be something in this.

Patient advocacy groups, and Biogen may be happy, but you still have the system cost of $56K per year, plus side effects of concern with little evidence of adequate benefits to balance all that out. Then there's the muddying of the waters as to what the FDA stamp of approval really means. To me it's been a very high standard, up until now, and that's exactly as it should be. I think that last concern, that this opens the door to more questionable approvals by lowering the bar, is actually the biggest concern I have.
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