Not sure which drug you’re talking about; perhaps both. But favorable results have been observed for both, clinically. If they have not been proved effective in double blind tests meeting all the FDA criteria for drug testing doesn’t mean they haven’t been been useful in humans. Meeting FDA criteria does not necessarily guarantee safety or effectiveness clinically. Maybe all the class action ads on TV against drug companies are bogus, but I doubt it. Every one of those drugs passed FDA approval.
I’m sure most everybody is aware of the ostensible reason. But just because this guy complains to the left wing media doesn’t make it true. And even if true, what does it actually tell us?
Bright complains that he was “bypassed” by his superior; in other words, Bright is in a power struggle with his superior. And his “long-standing relationship” is what? Kadlec probably has “long standing relationships” with nearly every drug manufacturer, but that doesn’t make it nefarious.
And are people supposed to say nothing if a potential customer is a “friend” (if that’s even the truth) of a famous and highly-placed person?
But I think the first statement buttons it. Bright is a vain man who thought he should have more authority than his superior who actually had more authority than he did. Lots of those kinds in the world, and they don’t endear themselves to their superiors or deserve to be.
At this point it is only a “maybe”. That may change soon, but not yet. And yes, I was referring to both drugs.
I never said it hasn’t been useful in humans. I said we don’t know if it has been useful in humans.
There are many levels of FDA approval. It is confusing to talk about “FDA criteria” without specifying which level you are talking about.
Why? If they determine the criteria levels and which things have to meet what, then we’re putting total faith in the FDA even so.
It is confusing when you talk about “FDA criteria” without specifying what the criteria is for because the criteria are very different depending on what kind of usage is being approved. Approval for selling drug to treat an illness in all circumstances is much stricter than the very narrow approval needed for an Emergency Use Authorization. The problem I see here is that people are citing the EUA from the FDA as if it were some higher form of approval than an EUA requires. And EUA requires almost nothing, except for safety. That is always a requirement. But as for effectiveness, that is not needed ahead of time for use in clinical trials. Otherwise there could be no clinical trials because that would be a catch-22.
Of course. I never said otherwise. The only quibble I would have with what you said is that I have difficulty believing the FDA would approve emergency use for something that someone simply brought to them without having some rational basis for doing it, e.g., bringing in a cod liver oil formula mixed with ethanol to cure cancer. I doubt safety is the only consideration.
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