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Posted On: 04/04/2024 10:56:15 AM
Post# of 148863
drug pulled from market - that should have never been approved in the first place.
https://finance.yahoo.com/news/als-drug-pulle...59610.html
Amylyx Pharmaceuticals ALS drug - Relyvrio - pulled for being ineffective. drug was LOBBIED in congress to be approved by patients and advocates, and FDA caved. just like aduhelm, the pressure was great enough to grant approval, with data from tiny trials.
at least Relyrio has minor side effects. core of the issue is the test used to quantify patient response to drug is based on patient opinion on how they feel (long covid?). doctors noted that some patients claimed to be improving (walking, swallowing etc) where doctors could clearly see they are not. this concept will muddy our waters when it comes to long covid/leronlimab. on the one hand, if a patient in a trial believes they are "feeling better", how is that data truly certified? on the other hand, if there is enough outside pressure to approve a drug, when and how does the FDA loosen the reigns and approve?
https://apnews.com/article/science-business-h...d608960a05
"For deadly diseases like cancer, one study showing promising early results is often accepted." - lets hope the rules the FDA operate on are consistent enough
“They essentially capitulated to both industry and patient advocacy pressure, as opposed to abiding by the science.” - lets hope the FDA knows what science is
“I would prefer the FDA wait for two trials,” he (Rothstein, the Johns Hopkins researcher) said. “Patients will say, ‘You’re depriving me of a drug.’ And the counter to that is: ‘I may be depriving you of a drug that isn’t effective.’” - lets hope we are not entering an era where not even 2 trials is enough
https://finance.yahoo.com/news/als-drug-pulle...59610.html
Amylyx Pharmaceuticals ALS drug - Relyvrio - pulled for being ineffective. drug was LOBBIED in congress to be approved by patients and advocates, and FDA caved. just like aduhelm, the pressure was great enough to grant approval, with data from tiny trials.
at least Relyrio has minor side effects. core of the issue is the test used to quantify patient response to drug is based on patient opinion on how they feel (long covid?). doctors noted that some patients claimed to be improving (walking, swallowing etc) where doctors could clearly see they are not. this concept will muddy our waters when it comes to long covid/leronlimab. on the one hand, if a patient in a trial believes they are "feeling better", how is that data truly certified? on the other hand, if there is enough outside pressure to approve a drug, when and how does the FDA loosen the reigns and approve?
https://apnews.com/article/science-business-h...d608960a05
"For deadly diseases like cancer, one study showing promising early results is often accepted." - lets hope the rules the FDA operate on are consistent enough
“They essentially capitulated to both industry and patient advocacy pressure, as opposed to abiding by the science.” - lets hope the FDA knows what science is
“I would prefer the FDA wait for two trials,” he (Rothstein, the Johns Hopkins researcher) said. “Patients will say, ‘You’re depriving me of a drug.’ And the counter to that is: ‘I may be depriving you of a drug that isn’t effective.’” - lets hope we are not entering an era where not even 2 trials is enough
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