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The process has its flaws. Poorly designed drugs make it through the FDA process. Blind following is foolish. Skepticism is healthy. I don't get software update

The process has its flaws. Poorly designed drugs make it through the FDA process. Blind following is foolish. Skepticism is healthy. I don't get software updates as soon as available because, even with the testing, peer reviews, flaws still happen. Further, there were big political and financial reasons to push the vaccines through. Those are all conflicts of interest. Pfizer had millions of doses manufactured before approval. If trial results didn't look good, they certainly had the incentive to "massage" the results to get it approved and get those millions of doses sold rather than a huge loss. As the original poster shared, it should be a considered a reasonable position to be skeptical of small scale results. Pfizer's position appears to have scaled well (Moderna as well). 100s of millions of doses across diverse populations show its relative safety and efficacy.

acdha 5y ago
I'm not saying it's perfect but rather that the skepticism you're looking for is found within the process where many scientists who are not employed by the vendor review the test results, methodology, and side effects. By the time something gets through approval, it's been tested in thousands of people with monitoring over a substantial time period (even the EUA COVID vaccines were monitored for a period of time longer than vaccine side effects have historically been observed) and reviewed by hundreds of people. We actually have an interesting example which I think validates that process even though it comes in the unlikely form of the FDA's recent mistake approving Aducanumab. There is a lot of criticism, including IG investigations, over the approval because it was approved despite having failed to go through the process successfully. The Phase III trials were cancelled after they concluded that the drug was not successful, the FDA's internal scientific review found it did not meet the mark, and the outside scientific advisory panel rejected it so strongly that multiple panel members resigned after it was approved anyway. That to me seems like a pretty good argument that the process was doing what we expect and the way to avoid expensive mistakes is to follow it.
wildmanx 5y ago
You are welcome to be skeptical. But in the meantime, don't cause me to not be able to get a potentially life-saving drug. You may think it's a money grab or not tested enough or a conspiracy or a conflict of interest. Fine, don't take it. But I still want it. 1.4 million with ridiculously small number of question mark cases are good enough for me. They don't have to be for you. But let me have it. I pay for it.
- daddylongstroke 5y ago
  I don't think any skeptics caused you to not be able to get a potentially life-saving drug. If they have, please show examples. Lyme disease is not life threatening. GSK didn't go through with distribution because it didn't make business sense.

acdha 5y ago

I'm not saying it's perfect but rather that the skepticism you're looking for is found within the process where many scientists who are not employed by the vendor review the test results, methodology, and side effects. By the time something gets through approval, it's been tested in thousands of people with monitoring over a substantial time period (even the EUA COVID vaccines were monitored for a period of time longer than vaccine side effects have historically been observed) and reviewed by hundreds of people. We actually have an interesting example which I think validates that process even though it comes in the unlikely form of the FDA's recent mistake approving Aducanumab. There is a lot of criticism, including IG investigations, over the approval because it was approved despite having failed to go through the process successfully. The Phase III trials were cancelled after they concluded that the drug was not successful, the FDA's internal scientific review found it did not meet the mark, and the outside scientific advisory panel rejected it so strongly that multiple panel members resigned after it was approved anyway. That to me seems like a pretty good argument that the process was doing what we expect and the way to avoid expensive mistakes is to follow it.

wildmanx 5y ago

You are welcome to be skeptical. But in the meantime, don't cause me to not be able to get a potentially life-saving drug. You may think it's a money grab or not tested enough or a conspiracy or a conflict of interest. Fine, don't take it. But I still want it. 1.4 million with ridiculously small number of question mark cases are good enough for me. They don't have to be for you. But let me have it. I pay for it.

daddylongstroke 5y ago
I don't think any skeptics caused you to not be able to get a potentially life-saving drug. If they have, please show examples. Lyme disease is not life threatening. GSK didn't go through with distribution because it didn't make business sense.