No one cares about any of this stuff. Rules need to be tossed aside to minimize loss of life. All FDA rules surrounding drugs need to be suspended for COVID19 patients. We need to start doing what china did and start using non approved anti-virals to save people's lives.
We need to start vaccinating at risk populations(75 or older) with the trial vaccine if it is shown to be effective in the upcoming weeks. We cant wait a year.
Woah there. Don't be so hasty to throw out the baby with the bathwater.
Don't need another Thalidomide dropped on us just because things are looking a bit grim. It's one thing to ask "Do we really need to let this stand in our way right now?"; It's an entirely different kettle of fish to say "Screw it, if it kills the virus anything goes!"
>Woah there. Don't be so hasty to throw out the baby with the bathwater.
Agreed. I may absolutely hate the documentation I have to complete as a microbiologist in a GMP company, but there is a reason for it. I just wish that GMP wasn't filled with so much BS. The parent comment here is being ridiculous and deserves to be argued against.
So when given a choice to a 65 year old to die or take an unapproved drug. We should let them die. We are going to run out ventilators and will ration them. Our hospitals are already at capacity. Italy is at 8% mortality rate and climbing. We need to do anything to cut icu rate and spread. Virus is showing long term effects even in children. Known long terms issues is worse than hypothetical issues. Cautious thinking is why western civilization has failed to contain the virus.
>So when given a choice to a 65 year old to die or take an unapproved drug.
Did not say that. Allow them to elect to take the drug, however, we still need to follow up, and keep track of the outcomes. Data is critical to avoid outcomes where we end up dropping bombs on houses to put out the housefire. Again, see Thalidomide.
>We are going to run out ventilators and will ration them.
Likely. I also believe that there should be a much greater tolerance allowed for expediting supply chains to make components for new ones; but data is also key. A fabrication method that results in immediate complications needs to have a quickly followed audit trail to ensure remedial action can take place quickly to minimize additional harm. That doesn't mean you can't compromise on some non or less critical tolerances while you're at it.
>Virus is showing long term effects even in children.
Noted, let's try not to add onto that by releasing something untested that causes severe side-effects as well.
>Known long terms issues is worse than hypothetical issues.
Difference: the known long term issues from the virus alone would happen with or without intervention in some portion of the population. Long term issues that arise as a complication via treatment would not happen except that weren't diligent enough.
Many of the GxP's are, in fact, written in blood. I'm fine with getting adventurous and experimenting, but we need to be tracking outcomes so interventions can take place at the first sign of trouble too.
It isn't easy. Quality never is. There is a damn good reason for you to put in the extra work to make it happen regardless.
We need to start vaccinating at risk populations(75 or older) with the trial vaccine if it is shown to be effective in the upcoming weeks. We cant wait a year.