4 ms·

> This literally takes an army of people working after hours,” said Gholam. “There are tireless, really unsung heroes at the UH research office who make this ha

> This literally takes an army of people working after hours,” said Gholam. “There are tireless, really unsung heroes at the UH research office who make this happen for every patient – they have to do this over and over and over.” Forty-seven times in the last 10 years to be exact. Ohh, the poor guys have to hand in 4.7 forms per year to get access to an unapproved medicine they need. I would've thought it was satire, but it seems you're serious? Amazing.

smeej 4y ago
Why is something that's been approved in Europe for 30 years still waiting for FDA approval in the first place? If they issue the medication immediately after the form is submitted, without further inquiry or scrutiny (which is actually good in the case of something this urgent), why are they even bothering keeping it under such lock and key anyway? That's what would sound like satire to anyone without an unflinching faith in the importance of a nanny state.
- s1artibartfast 4y ago
  The point is to track and monitor its use if it is not approved. The inquiry and scrutiny exists. Im not sure why you assume it doesnt. Do all of the patients die from the drug? Are doctors administer it as a new fad for the common cold, ect?
  - smeej 4y ago
    I assume it doesn't because U.S.-government-level "inquiry and scrutiny" takes at least an order of magnitude longer than 72 hours. If they're getting this done in time for it to be useful, it's just being rubber-stamped. Do you sincerely think the EU would keep a drug available for common use if everyone who took it died? If not, drop the red herring and try to have a halfway serious discussion.
    - 411111111111111 4y ago
      I mean the argument was that that "they have to keep filling out these forms, causing lots of overtime", that was the argument I pointed out to be unreasonably dumb considering it's less then 5 times per year. So... The one that's doing that is pretty much you. None of us can argue about wherever the drug should be approved by now, as we don't know why it isn't yet. You'd have to first get a statement from the agency before that discussion can take place
    - s1artibartfast 4y ago
      I do think there is patient tracking after the fact, and that the reason for exemption is examined. >Do you sincerely think the EU would keep a drug available for common use if everyone who took it died? No, but this is the type of data the FDA will collect and verify. It is not an approved product so they don't have this data tracking on it like they would for a normal product. I guess I dont think your central point is credible. You dont think that a form can be examined to see if it has a doctors approval and valid need within 72 hours? Here is the process if you want to educate yourself: https://www.fda.gov/news-events/expanded-access/expanded-access-how-submit-request-forms#PhysicianEmergency-sbs https://www.fda.gov/news-events/expanded-access/expanded-acc...
TomSwirly 4y ago
Oh, no, the amazing person is definitely you here. Here's a life-saving drug that US pharmacists (only) are not allowed to stock; a drug that saves lives but only if given in a small time windows; and to get this drug you need to fill out a form and simply hope that someone happens to be working at whatever time you start to die. And here you are, making fun of people who think this is a ridiculous idea! Who wrote this? Death?
- 411111111111111 4y ago
  Yes, let's let doctors give out unapproved drugs whenever they want so they can finally properly profit by making their own premium drug brands. Really smart ideas, i totally agree. My previous astonishment was clearly misplaced, these doctors know best after all.

smeej 4y ago

Why is something that's been approved in Europe for 30 years still waiting for FDA approval in the first place? If they issue the medication immediately after the form is submitted, without further inquiry or scrutiny (which is actually good in the case of something this urgent), why are they even bothering keeping it under such lock and key anyway? That's what would sound like satire to anyone without an unflinching faith in the importance of a nanny state.

s1artibartfast 4y ago
The point is to track and monitor its use if it is not approved. The inquiry and scrutiny exists. Im not sure why you assume it doesnt. Do all of the patients die from the drug? Are doctors administer it as a new fad for the common cold, ect?
- smeej 4y ago
  I assume it doesn't because U.S.-government-level "inquiry and scrutiny" takes at least an order of magnitude longer than 72 hours. If they're getting this done in time for it to be useful, it's just being rubber-stamped. Do you sincerely think the EU would keep a drug available for common use if everyone who took it died? If not, drop the red herring and try to have a halfway serious discussion.
  - 411111111111111 4y ago
    I mean the argument was that that "they have to keep filling out these forms, causing lots of overtime", that was the argument I pointed out to be unreasonably dumb considering it's less then 5 times per year. So... The one that's doing that is pretty much you. None of us can argue about wherever the drug should be approved by now, as we don't know why it isn't yet. You'd have to first get a statement from the agency before that discussion can take place
  - s1artibartfast 4y ago
    I do think there is patient tracking after the fact, and that the reason for exemption is examined. >Do you sincerely think the EU would keep a drug available for common use if everyone who took it died? No, but this is the type of data the FDA will collect and verify. It is not an approved product so they don't have this data tracking on it like they would for a normal product. I guess I dont think your central point is credible. You dont think that a form can be examined to see if it has a doctors approval and valid need within 72 hours? Here is the process if you want to educate yourself: https://www.fda.gov/news-events/expanded-access/expanded-access-how-submit-request-forms#PhysicianEmergency-sbs https://www.fda.gov/news-events/expanded-access/expanded-acc...

TomSwirly 4y ago

Oh, no, the amazing person is definitely you here. Here's a life-saving drug that US pharmacists (only) are not allowed to stock; a drug that saves lives but only if given in a small time windows; and to get this drug you need to fill out a form and simply hope that someone happens to be working at whatever time you start to die. And here you are, making fun of people who think this is a ridiculous idea! Who wrote this? Death?

411111111111111 4y ago
Yes, let's let doctors give out unapproved drugs whenever they want so they can finally properly profit by making their own premium drug brands. Really smart ideas, i totally agree. My previous astonishment was clearly misplaced, these doctors know best after all.