Should the FDA approve a drug despite uncertainties about its effectiveness?

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LizziB

Community manager

Edited on 09/12/2022 at 12:18 PM

Good advisor

Hi everyone,

How are you today?

The Food and Drug Administration (FDA) has been in the news recently about whether they will approve a drug for the debilitating disease Amyotrophic lateral sclerosis (ALS). The reason why this is controversial is because advisors have recommended to approve the drug despite uncertainties about its effectiveness. The only trial contained less than 200 participants. But it could be very beneficial for those suffering from ALS seeing as it will be the first new drug for the disease in 5 years.

Should the FDA approve drugs that may help patients suffering from chronic or degenerative diseases without extensive trials? Would you take a drug with FDA approval but few trial participants? What do you think?

Please share your experiences and thoughts!

Take care,

Lizzi

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seattlelife

11/15/2022 at 10:37 AM

Hi @LizziB

This is an interesting topic. Yes I think it would be okay for them to release drugs without a lot of information, I kind of already feel they do this. Also, for rare diseases, they probably don't have enough people to trial it on so how would they ever get any new drugs.

But that's just my opinion...

Should the FDA approve a drug despite uncertainties about its effectiveness? https://www.carenity.us/forum/other-discussions/news-from-the-media/should-the-fda-approve-a-drug-despite-uncertai-4847 2022-11-15 10:37:20

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LizziB

Community manager

11/17/2022 at 7:09 PM

Good advisor

HI @seattlelife

How are you today?

Thank you for your opinion. I think many people don't understand how complicated clinical trials can be and how hard it is to recruit participants. I will tag a few other members who may suffer from or know someone suffering from a rare condition to see if they have other thoughts on this topic.

@AlphaBehemonth @TCoffey @Funfun111 @Maryjean @Andagain @Nurscutie @Nylahkay21 @KO_Migraine @Susan-Jane @Tnewman @Sarah1004 @Mustang08 @Natassia @cathybuffalo @Bearbo @Skinsfan23693 @Twettybird @PaulaKay

Take care,

Lizzi

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