OT: 83rd Obsequious Banter Thread: Balls to the Wall

[Lord Defect]

Totally different foods here, one is a sandwich and the other is a steak

That’s my view on pulled pork vs brisket as well. Brisket is in another league.

 

[Beef Invictus]

Third member of FDA expert committee resigns over Alzheimer's decision

OK, I'm not informed here. What I've read/heard, the problem is that it merely slows progression instead of reversing it.

What's the problem with that?

@DancingPanther come enlighten me

 

[Captain Dave Poulin]

I can make a few dozen hot dogs for the price of a few quality steaks, but it doesn’t mean hot dogs are better.

I can put a few dozen hot dogs on a few dozen pieces of bread, but that doesn't mean that I have a few dozen sandwiches.

Also, hot dogs >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> steak.

 

[DancingPanther]

OK, I'm not informed here. What I've read/heard, the problem is that it merely slows progression instead of reversing it.

What's the problem with that?

@DancingPanther come enlighten me

I know nothing of this. Standby

 

[Embiid]

OK, I'm not informed here. What I've read/heard, the problem is that it merely slows progression instead of reversing it.

What's the problem with that?

@DancingPanther come enlighten me

I think even the slowing is negligible but have to research more....

In explaining the approval, the FDA acknowledged Aduhelm had not demonstrated a clear clinical benefit in terms of slowing disease progression, but argued that by removing the plaques, Aduhelm “is reasonably likely to predict a clinical benefit to patients.”

 

[DancingPanther]

I think even the slowing is negligible but have to research more....

Wrong.

@Beef Invictus

The issue is the slowing is all theoretical, and because it's theoretical and not proven, some people are butthurt.

There are no drugs that treat the disease, only the symptoms. There are meds out there that preserve memory by only months, and they're approved. Everything approved now only slows the progression. Alzheimer's has been widely HYPOTHESIZED to be caused by the buildup of amyloid beta in the brain. This drug was tested on people with Alzheimer's who didn't show any statistically significant improvement.

However, since it's been proven to combat the buildup of amyloid beta, it was approved by the FDA on those grounds; on the hypothesis that it could work in very early stage Alzheimer's, for example.

But some experts are arguing you can't act on what is essentially a hunch- that it's not how the process works. Which, honestly they're right. But, since it's also been proven safe, if you want my opinion I say go for it. This is an orphan drug so it got fast tracked (orphan drugs are special because they're for rare conditons or curative therapies for those with no known cure) so let's see how it works post-hoc.

 

[Embiid]

Wrong.

@Beef Invictus

The issue is the slowing is all theoretical, and because it's theoretical and not proven, some people are butthurt.

There are no drugs that treat the disease, only the symptoms. There are meds out there that preserve memory by only months, and they're approved. Everything approved now only slows the progression. Alzheimer's has been HYPOTHESIZED to be caused by the buildup of amyloid beta in the brain. This drug was tested on people with Alzheimer's who didn't show any statistically significant improvement.

However, since it's been proven to combat the buildup of amyloid beta, it was approved by the FDA on those grounds; on the hypothesis that it could work in very early stage Alzheimer's, for example.

But some experts are arguing you can't act on what is essentially a hunch- that it's not how the process works. Which, honestly they're right. But, since it's also been proven safe, if you want my opinion I say go for it. This is an orphan drug so it got fast tracked (orphan drugs are special because they're for rare conditons or curative therapies for those with no known cure) so let's see how it works post-hoc.

"This drug was tested on people with Alzheimer's who didn't show any statistically significant improvement."

RIGHT...so it is negligible or better yet inconclusive results thus far....

 

[Beef Invictus]

Wrong.

@Beef Invictus

The issue is the slowing is all theoretical, and because it's theoretical and not proven, some people are butthurt.

There are no drugs that treat the disease, only the symptoms. There are meds out there that preserve memory by only months, and they're approved. Everything approved now only slows the progression. Alzheimer's has been widely HYPOTHESIZED to be caused by the buildup of amyloid beta in the brain. This drug was tested on people with Alzheimer's who didn't show any statistically significant improvement.

However, since it's been proven to combat the buildup of amyloid beta, it was approved by the FDA on those grounds; on the hypothesis that it could work in very early stage Alzheimer's, for example.

But some experts are arguing you can't act on what is essentially a hunch- that it's not how the process works. Which, honestly they're right. But, since it's also been proven safe, if you want my opinion I say go for it. This is an orphan drug so it got fast tracked (orphan drugs are special because they're for rare conditons or curative therapies for those with no known cure) so let's see how it works post-hoc.

OK, this is exactly what if felt like. People being butthurt that it isn't blindly following the book, despite there being really no downside.

 

[DancingPanther]

OK, this is exactly what if felt like. People being butthurt that it isn't blindly following the book, despite there being really no downside.

I didn't read the actual study but yeah that's the gyst of it

I'm usually of the science book too but you gotta start somewhere, why not here? That's just my thought anyway

 

[Embiid]

OK, this is exactly what if felt like. People being butthurt that it isn't blindly following the book, despite there being really no downside.

I don't see it that harshly....I think critics have some fair points as well. Here is a good story about the controversy

Why the FDA approved a controversial Alzheimer’s drug | PBS NewsHour

 

[trostol]

Lupin returns at 3 am...weeeeeee

 

[ajgoal]

So the drug is safe? That should be all the criteria the FDA needs to approve. Beyond that should be between the doctor and the patient.

 

[Embiid]

Mom...the meatloaf!
Fewer Young Men Are in the Labor Force. More Are Living at Home

Bloomberg - Are you a robot?

 

[Embiid]

So the drug is safe? That should be all the criteria the FDA needs to approve. Beyond that should be between the doctor and the patient.

The issue is that they had all of two clinical trials one of which showed some benefit and another that showed no benefit at all. So it is not conclusive that the drug is safe or effective for that matter. If you read the transcript of the interview I posted or listen to it this is a key part...

And as far as between the doc and patient more like between the doc and pharma rep...lol

We have some signal that there might be some benefit for patient symptoms, and we are going to tell the company that they need to do another clinical trial. And if the results of that trial do not show benefit, then the FDA might revoke the approval, and it could end up being that those trials don't show benefit at all.

The issue with that is that the clinical trial takes three or four, five years. And so this drug will be on the market, patients will be using it without actually being certain that it has the ability to help them.

So the cost benefit analysis will really be done in the next 3-5 years...hopefully not too many people will be "butthurt"...

Yes, there is definitely a risk.

This drug can cause brain swelling and brain bleeding. And in the trial, about 40 percent of patients in the trial did experience that. Now, it is not quite as serious as it sounds, because most of those cases didn't actually produce any symptoms for patients. But some number did.

And about 6 percent of patients had to quit the trials because they — of the brain swelling or brain bleeding. So those can be serious side effects. And, as a result, anybody who takes this drug will have to have regular brain MRIs to check to see if their brain is experiencing anything like this.

In terms of the benefit that they found — and, as you said, in the beginning, only one trial found any benefit. Another completely identical trial did not find any benefit. The benefit in the trial that did seem to be positive is actually quite slight.

So, some of the scientists who were concerned and arguing against approval were saying, we don't have a slam-dunk here. We only have one trial that shows any possibility of benefit. And that benefit itself is pretty slight. And then, on the other side, we know that there is a risk. And so they were saying the potential benefit here doesn't outweigh the risk.

 

[Embiid]

High noon erection

Jeff Bezos' space mission ridiculed after rocket likened to giant todger

 

[Jack Straw]

 

[Tripod]

Hope some of you are watching the Frech Open. Fantastic tennis between Nadal and Joker

 

[Hollywood Cannon]

Hope some of you are watching the Frech Open. Fantastic tennis between Nadal and Joker

 

[Beef Invictus]

Tennis is dogwater.

 

[Tripod]

Tennis is dogwater.

Beef Invictus is boiled hot dog water

wait....would that make it soup?

 

[CanadianFlyer88]

Tennis is dogwater.

Wondered if you could ever top some of your awful food takes.

And, there it is. /Goldblum

 

[Jack Straw]

Tennis is dogwater.

I don't know about you but my dogs drink the same water that I do. And it's good water.

 

[Beef Invictus]

Beef Invictus is boiled hot dog water

wait....would that make it soup?

Yes

 

[Beef Invictus]

Yes

It's a broth

 

[Tripod]

It's a broth

I see someone is responding to their own posts again...