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FDA approving Alzhemer snake oil to fleece taxpayers?

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MichaelMay

Member
Jun 6, 2021
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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.
It's a REALLY bad idea to use the general public as test subjects. People think the corona vaccine (that went through extremely thorough testing in a short time period) is suspect and crap like this is only going to encourage the idea that the FDA is bought and paid for by big Pharma.

From what I can tell there have been no positive results AT ALL above what placebo does in early onsets and looking at the formulation of the drug (a methyl chain specifically) it would fry the liver in the dosages required.

There already is another variant that works with once a week intramuscular injections where that wouldn't be a problem but it's not as "convenient" and it comes from BioNTech, it's not approved for anything by the FDA but is in third trial in Spain, Sweden and Finland where it will be rolled out later this year if all goes according to plan. BioNTech has already signed with a European producer though so that might have something to do with the very politically motivated and lobbied FDA's decision.
 

Steltek

Platinum Member
Mar 29, 2001
2,816
594
136
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.
Actually, it won't go "through the roof" at all, because Medicare doesn't pay for any drugs beyond immunosupressive drugs for kidney transplant recipients.

Drugs are covered under Medicare Part D plans or Medicare Advantage (which usually includes a Part D plan as its drug coverage), both of which are partially subsidized Medicare add-ons provided by private health insurance companies. Each of those plans control the drugs they provide coverage for. It is rare that Part D/Advantage plans provide coverage for expensive drugs (much less ones that have no evidence supporting that they actually work), so this will be a non-issue except for those people rich enough to pay for it out of pocket themselves.

The only way it will ever be widely used is if either the drug company heavily subsidizes it, or if private insurance plans decide paying that huge cost will benefit their bottom line.
 
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uclaLabrat

Diamond Member
Aug 2, 2007
4,568
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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.
My company went into a BLA filing a few years back for a drug used for an indication with probably a worse quality of life than alzheimers. A competitor wasn't far behind in filing their drug. Our product had a similarly brutal adcom as the one mentioned here, as did the competing drug.

Our product got a CRL, the competitor was approved a few months later. Similar mechanism, FDA overruled their own adcom and approved the competitor's drug since there were no alternatives, and our safety profile was deemed inferior.

Part of the approval was to generate data from a larger scale clinical trial, which wasn't even started until last year (several years after accelerated approval) and won't read out for several more. Overall it looks like that drug will be on the market for nearly a decade before there is likely a clear signal of confirmed benefit or not. Its a hell of a way to subsidize your drug development.
 
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uclaLabrat

Diamond Member
Aug 2, 2007
4,568
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The FDA process is too onerous.
LOL. Its really not. You should be able to prove that your drug works in a clinical setting. You should also be able to.prove that you can control the manufacturing process sufficiently so as to characterize the purity and potency of said product.

Is it ridiculously complicated? Of course. Each drug is a moon shot. And like a moon shot, if you want to do it right you better get your shit together.
 

MrSquished

Lifer
Jan 14, 2013
10,123
6,216
136
two people on an advisory board to the FDA resign in protest

Two members of a panel of outside advisors to the U.S. Food and Drug Administration have resigned in protest at the agency's decision to approve Biogen Inc's Aduhelm for treatment of Alzheimer's disease despite the committee’s recommendation against doing so.

Mayo Clinic neurologist Dr. David Knopman, a panel member who had been recused from the advisors’ November meeting to review the drug because he was an investigator in clinical trials of Biogen’s drug, said he resigned on Wednesday.


"I was very disappointed at how the advisory committee input was treated by the FDA," Dr. Knopman told Reuters. "I don't wish to be put in a position like this again.”

 

Meghan54

Diamond Member
Oct 18, 2009
9,995
2,942
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uclaLabrat

Diamond Member
Aug 2, 2007
4,568
922
136
Make that three members.

DOJ should be investigating both the company and FDA for corruption.
Why? Bad science doesn't mean corruption. Also (at least to my knowledge) the FDA is the sole arbiter of whether a drug can be marketed. The FDAs motives weren't due to corruption, they were more along the lines of compassionate use.
 
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IronWing

No Lifer
Jul 20, 2001
61,854
14,987
136
Why? Bad science doesn't mean corruption. Also (at least to my knowledge) the FDA is the sole arbiter of whether a drug can be marketed. The FDAs motives weren't due to corruption, they were more along the lines of compassionate use.
If the drug lacks efficacy, I don't see where compassion fits in. Might as well give a placebo.
 
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uclaLabrat

Diamond Member
Aug 2, 2007
4,568
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If the drug lacks efficacy, I don't see where compassion fits in. Might as well give a placebo.
I generally agree, but "compassionate use" is a specific program that was passed which enables the FDA to allow drugs to be used where efficacy has not been demonstrated (either due to early development stage or an off-label indication). Basically my theme here is unproven efficacy. Also, my understanding of the biogen drug was the phase 3 trial showed minimal benefit which may or may not be statistically significant, but again the FDA has wide leeway to determine what is acceptable, and in a case like alzheimers where there is no approved therapy, they often will take that stance as long as the safety profile is acceptable.

Again, is it good science? Of course not. But they've demonstrated a willingness to let that slide for patients with no other means of treatment. It was the same situation in the instance I discussed above; patients with no real treatment and no hope. The FDA will in those instances often put it on the market in case someone ends up an outlier.

So yes, bad science, not necessarily bad policy.
 
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IronWing

No Lifer
Jul 20, 2001
61,854
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I understand that idea but when the treatment costs enough that the price can significantly impact quality of life I don't see it as helpful.
 

Steltek

Platinum Member
Mar 29, 2001
2,816
594
136
I understand that idea but when the treatment costs enough that the price can significantly impact quality of life I don't see it as helpful.
Biogen is actually engaging in wishful thinking regarding the pricing. Most Medicare Part D plans and health insurance plans won't even cover non-generic drugs without having to fight with them over it, much less a drug that costs 56 grand a year.

I suspect the pricing was more about insider greed. By announcing they will sell the drug for 56k a year, the stock price jumped like 40% in the last few days. A lot of company insiders and Wall Streeters probably just made a lot of easy money over a lot of nothing..
 
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senseamp

Lifer
Feb 5, 2006
34,964
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Why? Bad science doesn't mean corruption. Also (at least to my knowledge) the FDA is the sole arbiter of whether a drug can be marketed. The FDAs motives weren't due to corruption, they were more along the lines of compassionate use.
Should be investigated to find out why FDA recommended against 10:1 vote by panel, lack of stage 2 study, failure of two stage 3 studies terminated as futile, and 40% brain swelling while delivering hardly measurable improvement in small subset in one of the failed studies. It's not bad science, it's deliberately ignoring good science. Since this potentially involves billions per year in Medicare funds, should be investigated by the DOJ to determine if any corruption occurred.
 

uclaLabrat

Diamond Member
Aug 2, 2007
4,568
922
136
Should be investigated to find out why FDA recommended against 10:1 vote by panel, lack of stage 2 study, failure of two stage 3 studies terminated as futile, and 40% brain swelling while delivering hardly measurable improvement in small subset in one of the failed studies. It's not bad science, it's deliberately ignoring good science. Since this potentially involves billions per year in Medicare funds, should be investigated by the DOJ to determine if any corruption occurred.
Again, you can argue corruption but there's no evidence. The adcom makes its recommendations based on science, as it should. The commissioner is under no legal or policy obligation to follow that guidance, which doesn't happen often but does happen. When the commissioner overrules an adcom, it's probably a policy based decision.
 

Meghan54

Diamond Member
Oct 18, 2009
9,995
2,942
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Biogen is actually engaging in wishful thinking regarding the pricing. Most Medicare Part D plans and health insurance plans won't even cover non-generic drugs without having to fight with them over it, much less a drug that costs 56 grand a year.

I suspect the pricing was more about insider greed. By announcing they will sell the drug for 56k a year, the stock price jumped like 40% in the last few days. A lot of company insiders and Wall Streeters probably just made a lot of easy money over a lot of nothing..

A few things...first, the price Biogen said it'll charge is the price, no wishful thinking. They've "justified" it by claiming it's cheaper than various cancer drugs, for what that's worth. But you sound like someone can/will make Biogen change its pricing for the drug, which is silly. There is no mechanism by which any entity in the U.S. can force Biogen to change its pricing...outside market pressure, which won't happen.

Why won't market pressures make Biogen change its pricing? Well, there are a few facts you need to consider in all this:

Federal law expressly prohibits Medicare from negotiating drug prices. What's probably the single largest insurance plan in the U.S. is prohibited from exercising any market forces to influence drug charged/list prices. You do know that, right? Medicare cannot dicker over drug pricing established by the mfgr. So who's going to challenge the pricing?

Second, Medicare is REQUIRED by Federal law to cover nearly every drug the FDA approves. Doesn't mean the drug has to be an improvement over current therapy or even be effective at all...just that the FDA approves the drug as safe for human consumption.

About the only thing that'll change the list price for the drug is public outcry, which will be loud for a week, then die down quickly as the target audience, those on Medicare, start asking for it from their MD's, cost be damned, because the new ads that are certain to be on continual rotation on Fox News, will spread the "hope and promise" of this new drug treatment for the dreaded Alzheimer's...and that's just too tempting a thread to not pull it, cost be damned. After all, that's exactly how the drug got approved in the first place...family and friends of Alz. patients, and pts. themselves, cried out to the FDA to approve the drug after the 11-member Peripheral and Central Nervous System Drugs Advisory Committee voted to not approve it.

There hasn't been an Alzheimer's drug approved in 20 years, so the sense of desperation is surely a major factor in the outcry to approve the drug.

Why? Interestingly, since this drug is an IV-only administered drug, it falls under unique Medicare rules.
(The below taken from an Axios article...)

Medicare Part B covers IV medications like Aduhelm that are administered in doctors' offices, and pays 106% of its average sales price, which usually hovers around the retail list price set by the drug company.

  • If Medicare decides to cover the drug with no restrictions, it would pay almost $59,000 annually for a course of treatment. Biogen could easily fetch tens of billions of dollars every year if fewer than 10% of the 6 million Alzheimer's patients get it.



Medicare patients have a 20% coinsurance rate on these drugs after they meet their deductible, so some patients could have to pay more than $10,000 in extra out-of-pocket costs, according to Juliette Cubanski, a Medicare policy expert at the Kaiser Family Foundation. This is the part that could potentially get some major outcry, except for the fact that Biogen, in a sign of being soft-hearted and kind, can waive the co-pay or reduce it, at will. So, if there's any blowback on price, it'll probably only effect the co-pay, not what Medicare pays.

Kaiser estimated that if only 500,000 Medicare patients ended up taking this drug, it'd cost Medicare $29 Billion/year.

And if there ever was a reason to rewrite/abolish the utter stupidity of not allowing Medicare to negotiate drug prices, this may end up being that turning point. This single drug could potentially cost so much that Medicare premiums skyrocket. Don't think the seniors that advocated for this drug to be approved even thought of this consequence...at all.

But as far as the list price right now? It is what it is and what will be charged until/unless we allow Medicare to haggle drug prices.
 
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uclaLabrat

Diamond Member
Aug 2, 2007
4,568
922
136
A few things...first, the price Biogen said it'll charge is the price, no wishful thinking. They've "justified" it by claiming it's cheaper than various cancer drugs, for what that's worth. But you sound like someone can/will make Biogen change its pricing for the drug, which is silly. There is no mechanism by which any entity in the U.S. can force Biogen to change its pricing...outside market pressure, which won't happen.

Why won't market pressures make Biogen change its pricing? Well, there are a few facts you need to consider in all this:

Federal law expressly prohibits Medicare from negotiating drug prices. What's probably the single largest insurance plan in the U.S. is prohibited from exercising any market forces to influence drug charged/list prices. You do know that, right? Medicare cannot dicker over drug pricing established by the mfgr. So who's going to challenge the pricing?

Second, Medicare is REQUIRED by Federal law to cover nearly every drug the FDA approves. Doesn't mean the drug has to be an improvement over current therapy or even be effective at all...just that the FDA approves the drug as safe for human consumption.

About the only thing that'll change the list price for the drug is public outcry, which will be loud for a week, then die down quickly as the target audience, those on Medicare, start asking for it from their MD's, cost be damned, because the new ads that are certain to be on continual rotation on Fox News, will spread the "hope and promise" of this new drug treatment for the dreaded Alzheimer's...and that's just too tempting a thread to not pull it, cost be damned. After all, that's exactly how the drug got approved in the first place...family and friends of Alz. patients, and pts. themselves, cried out to the FDA to approve the drug after the 11-member Peripheral and Central Nervous System Drugs Advisory Committee voted to not approve it.

There hasn't been an Alzheimer's drug approved in 20 years, so the sense of desperation is surely a major factor in the outcry to approve the drug.

Why? Interestingly, since this drug is an IV-only administered drug, it falls under unique Medicare rules.
(The below taken from an Axios article...)

Medicare Part B covers IV medications like Aduhelm that are administered in doctors' offices, and pays 106% of its average sales price, which usually hovers around the retail list price set by the drug company.

  • If Medicare decides to cover the drug with no restrictions, it would pay almost $59,000 annually for a course of treatment. Biogen could easily fetch tens of billions of dollars every year if fewer than 10% of the 6 million Alzheimer's patients get it.


Medicare patients have a 20% coinsurance rate on these drugs after they meet their deductible, so some patients could have to pay more than $10,000 in extra out-of-pocket costs, according to Juliette Cubanski, a Medicare policy expert at the Kaiser Family Foundation. This is the part that could potentially get some major outcry, except for the fact that Biogen, in a sign of being soft-hearted and kind, can waive the co-pay or reduce it, at will. So, if there's any blowback on price, it'll probably only effect the co-pay, not what Medicare pays.

Kaiser estimated that if only 500,000 Medicare patients ended up taking this drug, it'd cost Medicare $29 Billion/year.

And if there ever was a reason to rewrite/abolish the utter stupidity of not allowing Medicare to negotiate drug prices, this may end up being that turning point. This single drug could potentially cost so much that Medicare premiums skyrocket. Don't think the seniors that advocated for this drug to be approved even thought of this consequence...at all.

But as far as the list price right now? It is what it is and what will be charged until/unless we allow Medicare to haggle drug prices.
Medicare part D and the drug negotiations bullshit was one of the single biggest travesties of the Bush domestic policy.

We need single payer in a bad way.
 

senseamp

Lifer
Feb 5, 2006
34,964
4,979
126
Again, you can argue corruption but there's no evidence. The adcom makes its recommendations based on science, as it should. The commissioner is under no legal or policy obligation to follow that guidance, which doesn't happen often but does happen. When the commissioner overrules an adcom, it's probably a policy based decision.
Of course there's no evidence since there hasn't been an investigation.
Maybe it's policy based, or maybe it's regulatory capture based decision and commissioner involved has a job lined up after next turn of revolving door. With tens of billions of taxpayer dollars and very strange behavior involved in approving the drug, given the strong scientific consensus (10:0) against the drug being effective, this approval warrants a full DOJ inquiry.
"Usually, you need two big studies finding the same thing to approve a drug," NPR reported after the vote last year. But at that meeting, "the FDA asked its experts to focus only on the positive study, and it also presented analysis of the data that was really very favorable to the drug. All of that did not go over well with these advisers. Some of them seemed to feel like they were being railroaded by the FDA."
Seems like it was a rigged process from the beginning, the Feds need to get to the bottom of why that was.
 
Last edited:

Paratus

Lifer
Jun 4, 2004
14,721
8,022
146

There’s a lot to unpack here
  • $56k/ year medication - yay America!
  • Suggesting Alzheimer’s patients drive Ubers?
  • $57k/year part time Uber driver?
  • That username - wait a minute.

but wait there’s more!
 

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