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To: livius

You’re confusing things.

The vaccine approval process has been radically sped up with Operation Warp Speed. That is very different than discouraging cheap and safe therapeutics so as to help push expensive, patented products of sometimes dubious value.

The FDA and CDC together have done both.


38 posted on 10/06/2020 11:33:51 PM PDT by 9YearLurker
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To: 9YearLurker

No, I was talking about treatments, not the vaccine (if any).

Trump used a treatment that the FDA could approve generally but refuses to do so for the usual phony reasons (not tested enough, not proven, etc.). His access to it came through his physician, and because it is not FDA approved, it had to be provided through the “Right To Try” process, which gives patients the right to try an unapproved therapy. I think he had to sign a waiver to try it, or some such thing.

The thing that really impresses me is how the government authorities not only fail to look for treatments but actively block access to them. Remember when the governor of New Mexico (I think it was) actually prohibited doctors from prescribing HCQ in the state? I believe a lawsuit was filed and she had to reverse her order, but that she did it in the first place is pretty stunning.

They want people to continue to be terrified, to think that this is somehow the one disease in the world for which there is no treatment or cure, and that it’s a death sentence with no hope. They have found that stoking fear is the best way ever for controlling an entire population.

They’re mad at Trump for telling people to quit being afraid.


40 posted on 10/07/2020 5:38:38 AM PDT by livius
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To: 9YearLurker
"The vaccine approval process has been radically sped up with Operation Warp Speed."

The testing process is running as normal. The only things that changed with Operation Warp Speed are that no FDA bureaucrats can let the approval paperwork sit on their desk for six months while they take naps and drink on the job. And the other thing that's different is that President Trump negotiated with the manufacturers to have them begin making doses DURING the phase 3 clinical trials. That's a huge risk because it's extremely expensive to retool a factory to make your specific vaccine and there's no guarantee any of those doses will ever be approved. But doing that saves MONTHS of time to actually deliver doses versus waiting until after phase 3 trials are completed and approvals have been granted to even start retooling.

But the testing process remains the same as always. You run phase 1 clinical trials with a small group of closely monitored volunteers (~100 people). That looks just at safety, making sure you aren't going to kill anyone. Then you can move on to phase 2 clinical trials with a larger group of closely monitored volunteers (~1,000). Here you're mainly looking at what side effects are present and you get a little data about how well your candidate works. Then you can move on to phase 3 with tens of thousands (~30,000-50,000) closely monitored volunteers. This is where you get the full picture about both the safety and the efficacy of what you're testing. This must be completed before approvals are given.

They're all doing phase 1, phase 2, and phase 3 clinical trials for all these vaccine candidates. They have to demonstrate safety at every step of the way. If there's any question, the whole thing gets halted. The Oxford vaccine candidate has been held up for weeks because out of ~50,000 people, 1 person in the UK was in the hospital with a possible reaction to the vaccine candidate. After an investigation, UK medical authorities cleared the trials to continue, but the FDA has held them up for weeks over it. Anyone saying these are being rushed isn't paying attention.

43 posted on 10/07/2020 8:52:44 AM PDT by 2aProtectsTheRest (The media is banging the fear drum enough. Don't help them do it.)
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