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

[Commissar SFLUFAN]

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

 

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

A “disgraceful decision:” Researchers blast FDA for approving Alzheimer’s drug

ARSTECHNICA.COM

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

 

[Kal-El814]

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. 

[Joe]

Hope some of y’all had Biogen stock yesterday. Shit was poppin.

[LazyPiranha]

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.

[silentbob]

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

[Kal-El814]

1 minute ago, silentbob said:

I’m sure they have the cure for most diseases

 

They don’t.

[Jason]

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.

[Kal-El814]

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.

[CayceG]

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. 

[Jason]

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?

[Joe]

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?

[CitizenVectron]

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).

[silentbob]

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. 

[Commissar SFLUFAN]

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

 

"Doctors Resign From FDA Panel After Aducanumab Approval"

Two doctors have resigned from a prestigious panel after FDA approved a controversial Alzheimer's drug

WWW.BUSINESSINSIDER.COM

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The advisory panel voted in November that the FDA shouldn't approve the drug, called Aduhelm.

[Jason]

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.

[Joe]

I mean the study will definitely get filled, so I dunno what to tell you.

[Commissar SFLUFAN]

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

 

Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drug

WWW.CNBC.COM

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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.

 

[Jwheel86]

$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. 

[Commissar SFLUFAN]

FDA adviser who stepped down over Alzheimer's drug approval says there's no "good evidence that it works"

WWW.CBSNEWS.COM

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Dr. Aaron Kesselheim warned "there is a lot of evidence" the drug causes side effects and called the FDA's approval the "wrong decision."

 

Quote

A member of the FDA advisory committee who stepped down after the regulating body's approval of Aduhelm, a controversial new Alzheimer's drug, claims the treatment "showed no good evidence that it worked." 

Harvard professor of medicine Dr. Aaron Kesselheim, who also works at Brigham and Women's Hospital, called it the "worst drug approval decision in recent U.S. history" in his resignation letter. 

 

 

Why the Approval of That Alzheimer’s Drug Is So Disturbing

SLATE.COM

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It does do something.

 

[Guest]

I saw an interview that was interesting even if I wasn’t completely sold, but the basic idea was the FDA just created a $10 billion/year market for drugs to treat this condition and the first one doing very little gives even more incentive to aggressively fund the creation of drugs in the category that actually will be efficacious. 

[CitizenVectron]

13 minutes ago, sblfilms said:

I saw an interview that was interesting even if I wasn’t completely sold, but the basic idea was the FDA just created a $10 billion/year market for drugs to treat this condition and the first one doing very little gives even more incentive to aggressively fund the creation of drugs in the category that actually will be efficacious. 

 

I think that there is already a giant market that is desperate for treatment. It's not like putting out a bad drug is going to increase demand for a good one (imo).

[Iculus]

24 minutes ago, CitizenVectron said:

 

I think that there is already a giant market that is desperate for treatment. It's not like putting out a bad drug is going to increase demand for a good one (imo).

It won't increase demand. it will increase the willingness of companies to attempt to bring drugs to market.

[Guest]

23 minutes ago, CitizenVectron said:

 

I think that there is already a giant market that is desperate for treatment. It's not like putting out a bad drug is going to increase demand for a good one (imo).

It isn’t the demand, it’s that the FDA hasn’t approved an Alzheimer’s drug since…like the 90s. And now they have, a Biogen is going to make an obscene sum of money on a drug that doesn’t do much. You now have to be just a little better and can steal market share, and then the next a little better than that.

[Jason]

Creating a market by approving snake oil doesn't seem particularly smart no matter how you slice it.

[Guest]

6 minutes ago, Jason said:

Creating a market by approving snake oil doesn't seem particularly smart no matter how you slice it.

It’s been done before, and was successful. Should also be noted that the drug does do what it’s intended to do, removing plaque, it just seems as though what it does doesn’t positively affect the cognitive function of the patient to a significant degree.

[CitizenVectron]

Overall this drug is a massive failure for the health world (and patients), but it's the pinnacle of success for American medicine. Unlimited profit for something that does nothing. It might as well be Goop or shooting steam and rocks up people's buttholes for $50,000.

[Guest]

20 minutes ago, CitizenVectron said:

Overall this drug is a massive failure for the health world (and patients), but it's the pinnacle of success for American medicine. Unlimited profit for something that does nothing. It might as well be Goop or shooting steam and rocks up people's buttholes for $50,000.

It doesn’t do nothing, it removes plaque from the brain which is what it is supposed to do. But it seems despite Alzheimer’s researchers long believing the plaque was the cause of decline and removing it could slow, stop, or reverse, it doesn’t to any large degree thus far.

 

It could be that the development of the plaque is the sign of the harm, not the cause. Or any number of things. 

[Kal-El814]

10 hours ago, sblfilms said:

It doesn’t do nothing, it removes plaque from the brain which is what it is supposed to do. But it seems despite Alzheimer’s researchers long believing the plaque was the cause of decline and removing it could slow, stop, or reverse, it doesn’t to any large degree thus far.

 

It could be that the development of the plaque is the sign of the harm, not the cause. Or any number of things. 

 

Yeah. This is why the concept of “choice” in healthcare is really complicated and potentially dangerous. “Free market” stans often advocate for allowing more drugs to be approved and allowing patients to decide… but that’s a potentially dangerous idea for lots of medications. It’s not as simple as saying that’s a universally bad idea, since there are myriad instances where patients should be listened to and are capable of making informed decisions about their own care.

 

This specific example seems pretty bad, though.

[CitizenVectron]

11 hours ago, sblfilms said:

It doesn’t do nothing, it removes plaque from the brain which is what it is supposed to do. But it seems despite Alzheimer’s researchers long believing the plaque was the cause of decline and removing it could slow, stop, or reverse, it doesn’t to any large degree thus far.

 

It could be that the development of the plaque is the sign of the harm, not the cause. Or any number of things. 

 

I think the issue is that we have no proof that plaque causes the harm, or that removing it will help. Many drugs work and we don't fully understand why, and that's good enough to get them approved. But this drug should work (theoretically) but doesn't, so it's not good enough to be approved. 

 

A good comparison would be between Multiple Sclerosis and Vitamin D. We know that people with MS have reduced VitD levels. Is it caused by MS? Or is it a symptom of having MS? Many people, despite any evidence to the former, take huge amounts of D3, hoping it will help their MS. At least in the case of D3 it is cheap, readily available, and in reality, everyone probably needs more VitD than they get. But there is no evidence it works, even though we know low levels are associated with MS.

 

The only thing that matters is results, and if this drug can't show that it's helpful at all (and in fact, has strong side effects), then it should never be approved. It's like, here is the entire thing distilled in terms of how it should be:

 

Drug Company: This drug removes plaque.

People: That's awesome! Does removing plaque improve Alzheimer's? 

Drug Company: No

FDA: DENIED

 

Hopefully insurance companies and governments deny coverage for this. Unfortunately, that will likely mean people pay out of pocket in Mexico and Russia (or the US) to get their own private supply that does nothing, but still bankrupts them.

[Jason]

Controversial Alzheimer’s drug could cost US $334B—nearly half of DoD budget

ARSTECHNICA.COM

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Despite unproven efficacy, Biogen set the drug’s list price at $56,000 per year.

 

[Kal-El814]

24 minutes ago, Jason said:

Controversial Alzheimer’s drug could cost US $334B—nearly half of DoD budget

ARSTECHNICA.COM

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Despite unproven efficacy, Biogen set the drug’s list price at $56,000 per year.

 

This is why anyone and everyone that says pharmas would discover effective cures and then sit on them can feast on my poop. 

[Gavin King]

On 6/22/2021 at 9:10 AM, CitizenVectron said:

 

I think the issue is that we have no proof that plaque causes the harm, or that removing it will help. Many drugs work and we don't fully understand why, and that's good enough to get them approved. But this drug should work (theoretically) but doesn't, so it's not good enough to be approved. 

 

A good comparison would be between Multiple Sclerosis and Vitamin D. We know that people with MS have reduced VitD levels. Is it caused by MS? Or is it a symptom of having MS? Many people, despite any evidence to the former, take huge amounts of D3, hoping it will help their MS. At least in the case of D3 it is cheap, readily available, and in reality, everyone probably needs more VitD than they get. But there is no evidence it works, even though we know low levels are associated with MS.

 

The only thing that matters is results, and if this drug can't show that it's helpful at all (and in fact, has strong side effects), then it should never be approved. It's like, here is the entire thing distilled in terms of how it should be:

 

Drug Company: This drug removes plaque.

People: That's awesome! Does removing plaque improve Alzheimer's? 

Drug Company: No

FDA: DENIED

 

Hopefully insurance companies and governments deny coverage for this. Unfortunately, that will likely mean people pay out of pocket in Mexico and Russia (or the US) to get their own private supply that does nothing, but still bankrupts them.

Unless there's big rebate dollars on it (Likely will be), I think most health plans will not have this on their formulary. Even with big rebates, Fully Insured plans aren't going to want to pay for it to get some back in rebates, and large enough self-insured payers are going to want this off of their coverage. It'll likely just be small plan sponsors who get forced to cover it as someone. For most, good and bad, only rich people who can pay out of pocket will get it, or not rich people will go bankrupt paying out of pocket because they're understandably desperate. Pretty crappy of FDA to pass the buck to insurance companies to not needlessly cover and pay for a drug that has not been shown to have positive outcomes.

[Guest]

The Child at the Center of a National Debate Over a Fraudulent Cancer Drug

SLATE.COM

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How Laetrile became a national sensation.

Thought this was an interesting story in regards to the general issue at hand

[Chadatog]

On 6/22/2021 at 10:10 AM, CitizenVectron said:

 

I think the issue is that we have no proof that plaque causes the harm, or that removing it will help. Many drugs work and we don't fully understand why, and that's good enough to get them approved. But this drug should work (theoretically) but doesn't, so it's not good enough to be approved. 

 

A good comparison would be between Multiple Sclerosis and Vitamin D. We know that people with MS have reduced VitD levels. Is it caused by MS? Or is it a symptom of having MS? Many people, despite any evidence to the former, take huge amounts of D3, hoping it will help their MS. At least in the case of D3 it is cheap, readily available, and in reality, everyone probably needs more VitD than they get. But there is no evidence it works, even though we know low levels are associated with MS.

 

The only thing that matters is results, and if this drug can't show that it's helpful at all (and in fact, has strong side effects), then it should never be approved. It's like, here is the entire thing distilled in terms of how it should be:

 

Drug Company: This drug removes plaque.

People: That's awesome! Does removing plaque improve Alzheimer's? 

Drug Company: No

FDA: DENIED

 

Hopefully insurance companies and governments deny coverage for this. Unfortunately, that will likely mean people pay out of pocket in Mexico and Russia (or the US) to get their own private supply that does nothing, but still bankrupts them.

Just listened to a great podcast that dealt with exactly this, talking to Dr. Aaron Kesselheim, one of the Dr's who resigned from the advisory panel.

 

Big Pharma’s big fraud with Dr. Aaron Kesselheim | Crooked Media

CROOKED.COM

They are called surrogate endpoints, and in this case is the big cause of all of the problems that @CitizenVectron pointed out.

[Commissar SFLUFAN]

Thanks for the bump @Chadatog - this is an article that I meant to post but slipped my mind!

 

How Aduhelm, an Unproven Alzheimer’s Drug, Got Approved - The New York Times

WWW.NYTIMES.COM

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Though some of its own senior officials said there was little evidence of benefit for patients, the F.D.A. nonetheless greenlighted Biogen’s Aduhelm, or aducanumab.