Thank you very much for watching that whole committee meeting and giving us insight into how it works. You are awesome! The regulatory capture is obvious from the outside, and you have shown how it works on the inside. 👍🏼
Thanks! You know, I was thinking it was going to be some small things. I remember someone commenting on the pregnancy portion on Twitter and I rushed to make a snarky comment, but watching through the meeting I realized they were far more concerned about pregnancies than I was led on. It does seem that, in general, hardly anyone really felt overtly positive about this drug. I believe only one person was vehemently against it, one was vehemently for, and most fell in the middle honestly leaning more towards no, and so to see a majority vote yes after all of the concerns raised was honestly quite shocking!
I bet it was shocking! That is very strange. I wonder what their work life outside of meetings is like. Do they have a lot of interaction with pharmaceutical reps? Is there pressure from one another to lean towards approving drugs, and the best some can do is whine about not really wanting to during the meeting? Have they fallen into some kind of habit of giving pharmaceutical companies the benefit of the doubt? It certainly isn't rigorous skeptical science that protects the public, following the mantra do no harm. 😕
Honestly, I wouldn't be surprised. Molnupiravir is in no way a safe drug, and so instead of ascribing greater skepticism and hesitancy you have people saying "well, we have nothing else, so let's try it"! It's even more shocking that, even if approved, they want to limit the scope of its usage by so much you hardly have any group that can take it and at that point instead of approving why not re-evaluate the efficacy? How ridiculous!
It is indeed disheartening to see how sausages are made. Although I did not have a chance to watch this one, I did watch the vaccine committee consider the Pfizer shots for 5-11 year olds in its entirety. and all I could do was shake my head.
BTW, I don't think the FDA ever does its own research or studies. It is up to the company seeking approval for the product to submit such data. I suppose the FDA might also take independent research into account, but it would be rather unusual for independent research to exist when it comes to a new drug.
Yeah I figured as much, I just wished they considered it with a higher level of scrutiny and skepticism. When many members and people from outside tell you to look at those studies, you would think the FDA would reconsider allowing the EUA application until after they do more work. It seems strange for several members of the FDA to remark in approval of the studies that they were shown after all of those concerns were raised. I guess I would have hoped for more precaution.
I'm thinking I may need to watch more of these. Based on what it seems there's a ton of stuff in these meetings that tend to be missed.
Thank you very much for watching that whole committee meeting and giving us insight into how it works. You are awesome! The regulatory capture is obvious from the outside, and you have shown how it works on the inside. 👍🏼
Thanks! You know, I was thinking it was going to be some small things. I remember someone commenting on the pregnancy portion on Twitter and I rushed to make a snarky comment, but watching through the meeting I realized they were far more concerned about pregnancies than I was led on. It does seem that, in general, hardly anyone really felt overtly positive about this drug. I believe only one person was vehemently against it, one was vehemently for, and most fell in the middle honestly leaning more towards no, and so to see a majority vote yes after all of the concerns raised was honestly quite shocking!
I bet it was shocking! That is very strange. I wonder what their work life outside of meetings is like. Do they have a lot of interaction with pharmaceutical reps? Is there pressure from one another to lean towards approving drugs, and the best some can do is whine about not really wanting to during the meeting? Have they fallen into some kind of habit of giving pharmaceutical companies the benefit of the doubt? It certainly isn't rigorous skeptical science that protects the public, following the mantra do no harm. 😕
Honestly, I wouldn't be surprised. Molnupiravir is in no way a safe drug, and so instead of ascribing greater skepticism and hesitancy you have people saying "well, we have nothing else, so let's try it"! It's even more shocking that, even if approved, they want to limit the scope of its usage by so much you hardly have any group that can take it and at that point instead of approving why not re-evaluate the efficacy? How ridiculous!
It is indeed disheartening to see how sausages are made. Although I did not have a chance to watch this one, I did watch the vaccine committee consider the Pfizer shots for 5-11 year olds in its entirety. and all I could do was shake my head.
BTW, I don't think the FDA ever does its own research or studies. It is up to the company seeking approval for the product to submit such data. I suppose the FDA might also take independent research into account, but it would be rather unusual for independent research to exist when it comes to a new drug.
Yeah I figured as much, I just wished they considered it with a higher level of scrutiny and skepticism. When many members and people from outside tell you to look at those studies, you would think the FDA would reconsider allowing the EUA application until after they do more work. It seems strange for several members of the FDA to remark in approval of the studies that they were shown after all of those concerns were raised. I guess I would have hoped for more precaution.
I'm thinking I may need to watch more of these. Based on what it seems there's a ton of stuff in these meetings that tend to be missed.