Analysis: U.S. FDA faces mounting criticism over Alzheimer’s drug approval
Category: Mental Health and Wellness
Via: hallux • 3 years ago • 21 commentsBy: Julie Steenhuysen Deena Beasley - Reuters
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.
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Let's stop posting articles such as was done 2 days ago until the dust settles.
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.
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Without getting too meta...what revelations?
55K? LoL jim, the company probably spends more than that on coffee stirring sticks.
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.
In case you have not noticed, your choir sings one tune and is full of preachers.
As long as you and yours can get it, right?
Gotta love libertarians
Wuhan lab "leak" was a hoax for one. The "administration" ordered the teargas to clear the way for a photo op for another.
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.
That is still unfolding, the study left out interviews with other agencies involved.
My state is now bringing a lawsuit over the ever increasing costs of insulin. It is getting to where the price is unreal.
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.
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.
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.
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
Every drug has side effects. Just listening to drug commercials is scary.
May cause heart attack, stroke, high blood pressure, etc.
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
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".
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.
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.