Analysis: U.S. FDA faces mounting criticism over Alzheimer’s drug approval

  

Category:  Mental Health and Wellness

Via:  hallux  •  4 months ago  •  21 comments

By:   Julie Steenhuysen Deena Beasley - Reuters

Analysis: U.S. FDA faces mounting criticism over Alzheimer’s drug approval
Biogen has said a confirmatory Aduhelm trial could take nine years to complete.

S E E D E D   C O N T E N T



In approving the first new Alzheimer’s drug in nearly 20 years, the U.S. Food and Drug Administration is taking its biggest risk yet with a strategy that allows new therapies onto the market without strong evidence that they work, regulatory and scientific experts say.

The Biogen Inc   (BIIB.O)   drug, Aduhelm, was authorized based on evidence that it can reduce brain plaques, a likely contributor to Alzheimer's, rather than proof that it slows progression of the lethal mind-wasting disease.

The FDA has granted so-called "accelerated approval" in more than 250 instances since 1992, mainly for rare diseases or small patient populations that have had no effective treatments available to them. In these cases, the agency requires that drugmakers conduct additional clinical trials to prove their therapy works, or face withdrawal from the market.

Aduhelm, however, is in a different league in terms of the number of potential patients and cost to the healthcare system.




In addition, the FDA approval ignored the recommendation of its outside advisors, who said Biogen did not provide enough evidence of clinical benefit. Three of the advisory panel’s members have resigned in protest  since the FDA decision was announced on Monday.





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Hallux
Sophomore Principal
1  seeder  Hallux    4 months ago

Let's stop posting articles such as was done 2 days ago until the dust settles.

 
 
 
Just Jim NC TttH
Senior Principal
1.1  Just Jim NC TttH  replied to  Hallux @1    4 months ago

It was approved. To hell with the $55K annual cost to obtain it. (SMDH)

Won't happen. The posts are done by people and people are emotion driven for the most part. Especially as you know Democrats and Liberal types. That may be a sweeping generalization but it is a proven fact. Actions based on feeeeeelings.

If that was a criteria for this site, there obviously, with the revelations brought forth the last few days, quite a few less hit pieces over the last 4 or more years..............and they continue to this day. 

But I am preaching to the choir.

 
 
 
Ender
Professor Principal
1.1.1  Ender  replied to  Just Jim NC TttH @1.1    4 months ago

[removed]

 
 
 
Trout Giggles
Professor Principal
1.1.2  Trout Giggles  replied to  Just Jim NC TttH @1.1    4 months ago
with the revelations brought forth the last few days,

Without getting too meta...what revelations?

 
 
 
Hallux
Sophomore Principal
1.1.3  seeder  Hallux  replied to  Just Jim NC TttH @1.1    4 months ago

55K? LoL jim, the company probably spends more than that on coffee stirring sticks.

 
 
 
Just Jim NC TttH
Senior Principal
1.1.4  Just Jim NC TttH  replied to  Ender @1.1.1    4 months ago

I was responding to my friend the seeders request in comment 1. If you have a problem with it perhaps you should ask him to approve or not. And those who live in glass houses really shouldn't throw stones.

 
 
 
Hallux
Sophomore Principal
1.1.5  seeder  Hallux  replied to  Just Jim NC TttH @1.1    4 months ago
But I am preaching to the choir.

In case you have not noticed, your choir sings one tune and is full of preachers.

 
 
 
Trout Giggles
Professor Principal
1.1.6  Trout Giggles  replied to  Just Jim NC TttH @1.1    4 months ago
To hell with the $55K annual cost to obtain it.

As long as you and yours can get it, right?

Gotta love libertarians

 
 
 
Just Jim NC TttH
Senior Principal
1.1.7  Just Jim NC TttH  replied to  Trout Giggles @1.1.2    4 months ago

Wuhan lab "leak" was a hoax for one. The "administration" ordered the teargas to clear the way for a photo op for another. 

 
 
 
Just Jim NC TttH
Senior Principal
1.1.8  Just Jim NC TttH  replied to  Trout Giggles @1.1.6    4 months ago

It was sarcasm. And a terrible revelation to those people who had great hopes that there was something. I heard that figure yesterday on the news and I about crashed my car.

 
 
 
Hallux
Sophomore Principal
1.1.9  seeder  Hallux  replied to  Just Jim NC TttH @1.1.7    4 months ago
The "administration" ordered the teargas to clear the way for a photo op for another.

That is still unfolding, the study left out interviews with other agencies involved.

 
 
 
Ender
Professor Principal
1.1.10  Ender  replied to  Just Jim NC TttH @1.1.8    4 months ago

My state is now bringing a lawsuit over the ever increasing costs of insulin. It is getting to where the price is unreal.

 
 
 
Just Jim NC TttH
Senior Principal
1.1.11  Just Jim NC TttH  replied to  Ender @1.1.10    4 months ago

Have a couple of diabetic friends and I never realized until recently just how costly that disease can be. Saw a meme the other day that went something like "If Covid shots are free and for the public health, why not Insulin?' and there was something else but I thought it was a good point.

 
 
 
Ender
Professor Principal
1.1.12  Ender  replied to  Just Jim NC TttH @1.1.11    4 months ago

It made me think of what some people complain about. How they say costs are passed on.

It seems to me that the drug companies keep increasing prices. Almost like they think. oh well, the insurance companies will pay for it.

If the prices keep going up, eventually so will the cost of insurance.

 
 
 
Kavika
Professor Principal
1.1.13  Kavika   replied to  Ender @1.1.12    4 months ago

Three Canadians invented insulin in 1921 and they sold their patent for the med to the University of Toronto for $1 because they wanted everyone to have it not to make a profit off of it. 

That lesson was lost on Joe Manchin's daughter.

 
 
 
Trout Giggles
Professor Principal
2  Trout Giggles    4 months ago

Now back to the topic. I see this as hope for people with Alzheimer's. Nine years is a long time to wait for a treatment that may or may not cause adverse side effects.

But one thing for sure, Biogen needs to figure out how to make this treatment affordable

 
 
 
Ender
Professor Principal
2.1  Ender  replied to  Trout Giggles @2    4 months ago

Every drug has side effects. Just listening to drug commercials is scary.

May cause heart attack, stroke, high blood pressure, etc.

 
 
 
Trout Giggles
Professor Principal
2.1.1  Trout Giggles  replied to  Ender @2.1    4 months ago

I was give an arthritis medication and the one time I read the pamphlet for a drug it scared the bewillikers out of me. Every third word was "death".

I now just take Aleve

 
 
 
Just Jim NC TttH
Senior Principal
2.1.2  Just Jim NC TttH  replied to  Ender @2.1    4 months ago

And it's really a sad state of affairs that they have to if even a minute number of cases are reported to avoid the great American pastime of "I'm gonna sue. You didn't tell me". Scares hell out of me when I see an ad on TV and my doctor "suggests" that maybe I should "try this for a month". 

 
 
 
Ender
Professor Principal
2.1.3  Ender  replied to  Just Jim NC TttH @2.1.2    4 months ago

To me it kinda reminds me of the covid vac. Are some people going to have a reaction? Of course. Does not mean it isn't safe for the majority of the population.

I admit I don't know much at all about this drug. It is just odd to me that three people would resign over the approval process.

Something isn't right in all of that.

 
 
 
Kavika
Professor Principal
3  Kavika     4 months ago

The proverbial ''shit'' has hit the fan on this approval. Three members of the advisory board resigning over this tends to lead one to ask for a hell of a lot more information.

 
 
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