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FDA approving Alzhemer snake oil to fleece taxpayers?

senseamp

Lifer
Feb 5, 2006
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From November:
An advisory committee to the US Food and Drug Administration largely concluded in a meeting on Friday that there is not enough evidence to support the effectiveness of the experimental Alzheimer's disease drug aducanumab -- and thus clinical data do not support approving the treatment.
...
In response to a question about whether it was reasonable to consider data from one positive study as the primary evidence of aducanumab's effectiveness for the treatment of Alzheimer's disease, none of the committee members voted yes -- 10 voted no and one was uncertain.
...
In response to one question about whether the positive study provides "strong evidence" that supports the effectiveness of aducanumab for the treatment of Alzheimer's disease, one committee member voted yes, eight voted no and two were uncertain.
...
And in response to a separate question about whether another smaller study provided supportive evidence of aducanumab's effectiveness, none of the committee members voted yes -- seven voted no and four were uncertain.
...
During the meeting, some of the committee members also raised concern that questions and data were presented to the panel in a way that was biased, "one-sided" or favorable to the drug.
...
In March 2019, Phase 3 clinical trials of aducanumab were discontinued because a futility analysis found the trials were unlikely to meet their primary goals at completion.
So, it was rejected, amirite?
Nice try!

Today:
The US Food and Drug Administration on Monday approved the use of the experimental drug aducanumab for early phases of Alzheimer's disease -- despite an FDA advisory committee concluding last year that there is not enough evidence to support the effectiveness of the treatment.
But you already knew that.

Seems like DOJ should be investigating whatever corruption is going on at the FDA.
 
Dec 10, 2005
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I don't think it is necessarily snake oil. However, they shouldn't have approved it without a clear efficacy signal in a prospective Phase 3 clinical trial. Biogen should have had to run a new trial with appropriate hypotheses they may have generated from the earlier analyses.

Patients may now turn to a drug with ambiguous data for efficacy, when the better option may be to continue participating in clinical trials.
 

senseamp

Lifer
Feb 5, 2006
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They are basically saying they'll test it post-approval. Meaning on taxpayer buck since now Medicare will reimburse it. It's basically FDA equivalent of this:
1623086050601.png
 

woolfe9998

Lifer
Apr 8, 2013
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What was the result of phase 1 clinical trials regarding the safety of the drug?

If this drug is well tolerated, then I see no reason it shouldn't get early approval pending post approval study. I know the efficacy data is limited and it probably either doesn't work or only works a little, but people with this disease deserve a chance of a better outcome.
 
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senseamp

Lifer
Feb 5, 2006
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What was the result of phase 1 clinical trials regarding the safety of the drug?

If this drug is well tolerated, then I see no reason it shouldn't get early approval pending post approval study. I know the efficacy data is limited and it probably either doesn't work or only works a little, but people with this disease deserve a chance of a better outcome.
Should Medicare and private insurers have to pay tens of thousands of dollars for this "chance" with taxpayer and ratepayer money if there is no convincing evidence that it improves things? FDA's own advisory panel lopsidedly recommended against approval.
 

woolfe9998

Lifer
Apr 8, 2013
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Should Medicare and private insurers have to pay tens of thousands of dollars for this "chance" with taxpayer and ratepayer money if there is no convincing evidence that it improves things? FDA's own advisory panel lopsidedly recommended against approval.
That's up to you, as a taxpayer. My answer is yes. I don't mind Medicare paying for it for a few years while it undergoes further study. Because I've seen the effect of dementia, and I want anyone with this disorder to have a chance of a better outcome.
 

MrSquished

Lifer
Jan 14, 2013
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That's up to you, as a taxpayer. My answer is yes. I don't mind Medicare paying for it for a few years while it undergoes further study. Because I've seen the effect of dementia, and I want anyone with this disorder to have a chance of a better outcome.
Same here. My dad died of Alzheimer's. Give it a few years then cut the cord if it's no good, but if it is, would be amazing.
 
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hal2kilo

Lifer
Feb 24, 2009
17,211
4,850
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From November:


So, it was rejected, amirite?
Nice try!

Today:

But you already knew that.

Seems like DOJ should be investigating whatever corruption is going on at the FDA.
Next, Medicare costs go through the roof. Bad to tease people with medicine that only appears to help in early intervention. Good luck with a diagnosis.
 

senseamp

Lifer
Feb 5, 2006
34,964
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That's up to you, as a taxpayer. My answer is yes. I don't mind Medicare paying for it for a few years while it undergoes further study. Because I've seen the effect of dementia, and I want anyone with this disorder to have a chance of a better outcome.
But it's not up to me. Since FDA approved it, now my Medicare taxes will go to pay for it, whether I mind it or not. I am fine with people paying for it or raising money from private charity, but Medicare should not be paying for something with such weak evidence of efficacy.
 
Dec 10, 2005
20,998
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What was the result of phase 1 clinical trials regarding the safety of the drug?

If this drug is well tolerated, then I see no reason it shouldn't get early approval pending post approval study. I know the efficacy data is limited and it probably either doesn't work or only works a little, but people with this disease deserve a chance of a better outcome.
Patients could have also enrolled in a trial for that chance at a therapy that works. Now they may miss out on those real opportunities and face severe financial toxicity with a commercial product that has pretty flimsy evidence of working.

I feel bad for patients, but we shouldn't be approving products on wishes. They should be approved on clearcut data.
 

woolfe9998

Lifer
Apr 8, 2013
13,126
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Patients could have also enrolled in a trial for that chance at a therapy that works. Now they may miss out on those real opportunities and face severe financial toxicity with a commercial product that has pretty flimsy evidence of working.
What do you mean "financial toxicity?" Is that another reference to the fact that taxpayer's are on the hook here?
 

woolfe9998

Lifer
Apr 8, 2013
13,126
8,162
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Next, Medicare costs go through the roof. Bad to tease people with medicine that only appears to help in early intervention. Good luck with a diagnosis.
Bit of a stretch to suggest that Medicare costs "go through the roof" based on one drug approval which Medicare will pay for up to a few years if it turns out not to work. Medicare pays for a lot of things. This is one.
 
Dec 10, 2005
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What do you mean "financial toxicity?" Is that another reference to the fact that taxpayer's are on the hook here?
Financial toxicity = patient forced to cover high drug costs. If someone isn't on Medicare and their current provider doesn't cover the drug, they're going to be up shit creek.

And the taxpayer being on the hook for Biogen's profits is just icing on the fucking cake. They should be showing us their product works before we start shelling out what could be billions per year, given AD prevalence.
 
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senseamp

Lifer
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People will now be given this likely snake oil at taxpayer expense instead of being enrolled in trials for drugs that could actually work, paid for by manufacturers.
Price of this drug is $56,000 dollars per year, (mostly paid by taxpayers through Medicare.) For something that has no real proof of effectiveness preventing cognitive decline.
 

senseamp

Lifer
Feb 5, 2006
34,964
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Bit of a stretch to suggest that Medicare costs "go through the roof" based on one drug approval which Medicare will pay for up to a few years if it turns out not to work. Medicare pays for a lot of things. This is one.
There's never just one cockroach. This drug is $56,000 per year. But they've lowered the standard to where a lot of drugmakers will want same deal. Get experimental approval with no evidence of effectiveness, fleece taxpayers for a few years of trials, and if it doesn't work, move on to the next snake oil. Biogen stock is up $20B today, so obviously the market expects it to fleece Medicare for $20B in the few years it's on the market. Several drugs like these and we are talking a real dent on Medicare finances for something with no proof.
 
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woolfe9998

Lifer
Apr 8, 2013
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Financial toxicity = patient forced to cover high drug costs. If someone isn't on Medicare and their current provider doesn't cover the drug, they're going to be up shit creek.

And the taxpayer being on the hook for Biogen's profits is just icing on the fucking cake. They should be showing us their product works before we start shelling out what could be billions per year, given AD prevalence.
The non-Medicare patient - who BTW, is not the most common profile for someone taking a dementia drug - is not forced to cover high drug costs. They don't have to take the drug. Which is the situation you advocate for anyway, that it not be available. So it's hardly a burden on them versus not approving the drug.

So far as corporate profits, it's a secondary issue so far as I'm concerned. I'm not going to say don't approve this drug because there's a possibility some corporation makes money and the drug turns out to not work after further study. The overall cost to the taxpayer is not going to be noticeable.
 

woolfe9998

Lifer
Apr 8, 2013
13,126
8,162
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There's never just one cockroach. This drug is $56,000 per year. But they've lowered the standard to where a lot of drugmakers will want same deal. Get experimental approval with no evidence of effectiveness, fleece taxpayers for a few years of trials, and if it doesn't work, move on to the next snake oil.
It should be handled case by case. My opinion pertains to this drug for this particular disorder.
 

senseamp

Lifer
Feb 5, 2006
34,964
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It should be handled case by case. My opinion pertains to this drug for this particular disorder.
Once you lower the standard, then how do you tell the next snake oil salesman he doesn't qualify for same treatment? We have equal protection clause.
 

woolfe9998

Lifer
Apr 8, 2013
13,126
8,162
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Once you lower the standard, then how do you tell the next snake oil salesman he doesn't qualify for same treatment? We have equal protection clause.
FDA handles these case by case. Equal protection does not apply to drug companies LOL.
 

senseamp

Lifer
Feb 5, 2006
34,964
4,979
126
FDA handles these case by case. Equal protection does not apply to drug companies LOL.
This was a 10-0 vote against approval by their own panel. Even in the company's own study, cognitive improvement was less than 1 point on 18 point scale, in cherrypicked patients in only in one out of 2 studies that were stopped as futile. 40% developed painful brain swelling. If they still approved it, and put Medicare on the hook for paying $56000 per year for it, what's the threshold for approval? Promise of a sufficiently good position after leaving FDA, most likely.
DOJ needs to investigate this.
 

woolfe9998

Lifer
Apr 8, 2013
13,126
8,162
136
This was a 10-0 vote against approval by their own panel. Even in the company's own study, cognitive improvement was less than 1 point on 18 point scale, in cherrypicked patients in only in one out of 2 studies that were stopped as futile. 40% developed painful brain swelling. If they still approved it, and put Medicare on the hook for paying $56000 per year for it, what's the threshold for approval? Promise of a sufficiently good position after leaving FDA, most likely.
DOJ needs to investigate this.
Which is why I asked about the results of phase 1 for safety. If there are serious safety concerns, then no, I agree they shouldn't approve it.
 

Matt390

Member
Jun 7, 2019
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But it's not up to me. Since FDA approved it, now my Medicare taxes will go to pay for it, whether I mind it or not. I am fine with people paying for it or raising money from private charity, but Medicare should not be paying for something with such weak evidence of efficacy.

This is why we should get rid of Medicare.
 

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