President Trump signs right to try law

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Hayabusa Rider

Admin Emeritus & Elite Member
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https://arstechnica.com/science/201...o-weaken-fda-according-to-lawmaker-behind-it/

The intent is clear. They're just using this as a situation because its easy to spin and the ignorant masses can't see anything wrong with it. There will be more though.

And if you want to be an indignantly stupid person like Haybusa Rider and believe that this isn't just the start of the type of shit they want:
https://arstechnica.com/science/2017/08/bucking-fda-peter-thiel-funds-patently-unethical-herpes-
vaccine-trial/

Still sore I handed you your ass. Why don't you cry snake oil and Steve Jobs? Thiel? Seriously? That was done OUTSIDE the US and there wasn't the LEGALLY MANDATED FDA involvement at all. There's nothing in the law that in any way allows this, but I suppose that if alien probing has addled your mind so you can't read legislation then hey that would be your problem.

If the intent is to weaken the FDA this is the wrong friggin law lad. Does that mean that pharma and politicians don't play games? I know better than your utterly ignorant self that it happens which is why anything put forward needs to be watched, as I have always said once the government becomes involved.in health care.

Do you even have a job remotely related to this field or have you once again pulled things out of your butt? I'll go with the latter.

Oh, genius since you know about all this, tell what happened with doxycycline and why, and how you knew without googling. The people that best know things are those who have no involvement in the field it seems.

Next up- jet fuel melts steel beams... BUSH DID IT!
 
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And from a data standpoint, I'm sorry, but randomly assigning sugar pills to some of the patients that will be dead anyway isn't going to tell you anything you don't already know and, in the end, makes no difference for these patients either way. Humans aren't rats or mice, regardless of what I think about the necessity of significant data--if you have a drug that shows 70% or more success in such patients, then I find it wholly unethical to withhold that from a randomized population that would otherwise survive, if not given a placebo.
That's not how most clinical trials work. For phase 3 trials, particularly in oncology, it's almost usually "standard of care" vs experimental treatment or "standard of care" vs experimental treatment + "standard of care". For established treatment spaces, no one is getting a sugar pill.

And plenty of drugs show some efficacy signal in Phase 2 trials, but then flop in Phase 3. For example, endpoints that are used in Phase 2 trials which show some clinical efficacy (e.g., progression-free survival) turn out to not be correlated with overall survival when the Phase 3 registrational trial rolls around. That's pretty much what happened with Avastin in the breast cancer space.
 

Hayabusa Rider

Admin Emeritus & Elite Member
Jan 26, 2000
50,879
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That's not how most clinical trials work. For phase 3 trials, particularly in oncology, it's almost usually "standard of care" vs experimental treatment or "standard of care" vs experimental treatment + "standard of care". For established treatment spaces, no one is getting a sugar pill.

And plenty of drugs show some efficacy signal in Phase 2 trials, but then flop in Phase 3. For example, endpoints that are used in Phase 2 trials which show some clinical efficacy (e.g., progression-free survival) turn out to not be correlated with overall survival when the Phase 3 registrational trial rolls around. That's pretty much what happened with Avastin in the breast cancer space.


I forgot you were evil too.