6 ms·

Not just safety, but also effectiveness. FDA checks whether the trial(s) to prove the drugs effectiveness were run correctly (eg. the randomization, the control

Not just safety, but also effectiveness. FDA checks whether the trial(s) to prove the drugs effectiveness were run correctly (eg. the randomization, the control group, etc.), if the statistical analysis was done right, if the endpoints are appropriate (response to treatment is not always objective) etc. etc. The FDA (and EMA in Europe) are the only thing that protects desperate patients from fraudsters, charlatans and pharma-companies just looking for a return on their investment.

wbl 2y ago
Remember the pandemic? The FDA had safety and effectiveness data by end of August for the vaccine and were unprepared to do an analysis in less than a few months. Nor did they consider drafting the party boys of the Ozarks to get the efficiency data faster. As a result the winter of 2020-2021 saw thousands of preventable deaths. There's also the part where distribution was done in a way that deliberately killed people so that racial equality goals could be met. Perhaps the worst example of this kind of thinking were teachers in SF getting vaccinated but school not starting again.
bhickey 2y ago
Ideally this is what would happen. In practice there have been very public failures in being overly cautious and aggressive. While Aduhelm reduces Aβ it has no clinically significant effect. Still, the FDA approved it. Mercifully it'll be discontinued in November. The covid vaccine represented a huge policy failure by the FDA. While people in nursing homes died in droves we got small clinical trials. When you've got 90 year olds in a congregate setting facing a 50% chance of death, maybe it's time to stop pretending thalidomide may be lurking around every corner. The pediatric trials were just as bad. Due to their sizing it was statistically impossible to detect rare adverse effects. Yet, vaccination was delayed for children while these fruitless trials ran. In my own experience I had a low cost, high throughput covid testing protocol ready to go in early April 2020. It took the FDA until August 2020 to provide templates and another month to grant emergency use authorization. We could've drastically ramped up testing when it was needed most of the FDA has treated an emergency like an emergency.
- _heimdall 2y ago
  Is it your opinion that trials for the Covid vaccine should have been skipped to vaccinate people earlier, or that proper trials should have actually been done to know the efficacy and safety before testing it on the public?
  - bhickey 2y ago
    Either would've been preferable to what was done. Waiting on a provably fruitless trial in the midst of pandemic is regulatory homicide. Throughout 2020, more than 9% of all people in nursing homes died of covid. Depending on age case fatality rates were upwards of 50%. The vaccine should've been offered to these people on a compassionate use basis. Even at the time it was obvious that actual harm posed by the virus vastly outweighed any hypothetical risk of adverse vaccine reaction. Drastically expanding the vaccinated population through compassionate use would have rapidly provided efficacy and safety data.
    - _heimdall 2y ago
      > Throughout 2020, more than 9% of all people in nursing homes died of covid. Depending on age case fatality rates were upwards of 50%. That's just about most difficult population to determine primary cause of death for. Most people in nursing homes have multiple comorbidities and a long list of medications. Its easy enough to know when someone died with Covid, its much more difficult (if not impossible) to know after the fact whether that's what caused their death or if the infection began after an existing condition worsened and weakened their immune system further. > Drastically expanding the vaccinated population through compassionate use would have rapidly provided efficacy and safety data. That wouldn't have helped get efficacy or safety data for the general public though. Vaccinating that population could absolutely have helped determine efficacy for that population and I agree it feels like a reasonable action given the potential risks for that population, but the data wouldn't be useful for the general public that are younger and/or in better health prior to infection.
      - bhickey 2y ago
zoobab 2y ago
"The FDA (and EMA in Europe) are the only thing that protects desperate patients from fraudsters, charlatans and pharma-companies just looking for a return on their investment." EMA has some people that were recruited from Big Pharma.

wbl 2y ago

Remember the pandemic? The FDA had safety and effectiveness data by end of August for the vaccine and were unprepared to do an analysis in less than a few months. Nor did they consider drafting the party boys of the Ozarks to get the efficiency data faster. As a result the winter of 2020-2021 saw thousands of preventable deaths. There's also the part where distribution was done in a way that deliberately killed people so that racial equality goals could be met. Perhaps the worst example of this kind of thinking were teachers in SF getting vaccinated but school not starting again.

bhickey 2y ago

Ideally this is what would happen. In practice there have been very public failures in being overly cautious and aggressive. While Aduhelm reduces Aβ it has no clinically significant effect. Still, the FDA approved it. Mercifully it'll be discontinued in November. The covid vaccine represented a huge policy failure by the FDA. While people in nursing homes died in droves we got small clinical trials. When you've got 90 year olds in a congregate setting facing a 50% chance of death, maybe it's time to stop pretending thalidomide may be lurking around every corner. The pediatric trials were just as bad. Due to their sizing it was statistically impossible to detect rare adverse effects. Yet, vaccination was delayed for children while these fruitless trials ran. In my own experience I had a low cost, high throughput covid testing protocol ready to go in early April 2020. It took the FDA until August 2020 to provide templates and another month to grant emergency use authorization. We could've drastically ramped up testing when it was needed most of the FDA has treated an emergency like an emergency.

_heimdall 2y ago
Is it your opinion that trials for the Covid vaccine should have been skipped to vaccinate people earlier, or that proper trials should have actually been done to know the efficacy and safety before testing it on the public?
- bhickey 2y ago
  Either would've been preferable to what was done. Waiting on a provably fruitless trial in the midst of pandemic is regulatory homicide. Throughout 2020, more than 9% of all people in nursing homes died of covid. Depending on age case fatality rates were upwards of 50%. The vaccine should've been offered to these people on a compassionate use basis. Even at the time it was obvious that actual harm posed by the virus vastly outweighed any hypothetical risk of adverse vaccine reaction. Drastically expanding the vaccinated population through compassionate use would have rapidly provided efficacy and safety data.
  - _heimdall 2y ago
    > Throughout 2020, more than 9% of all people in nursing homes died of covid. Depending on age case fatality rates were upwards of 50%. That's just about most difficult population to determine primary cause of death for. Most people in nursing homes have multiple comorbidities and a long list of medications. Its easy enough to know when someone died with Covid, its much more difficult (if not impossible) to know after the fact whether that's what caused their death or if the infection began after an existing condition worsened and weakened their immune system further. > Drastically expanding the vaccinated population through compassionate use would have rapidly provided efficacy and safety data. That wouldn't have helped get efficacy or safety data for the general public though. Vaccinating that population could absolutely have helped determine efficacy for that population and I agree it feels like a reasonable action given the potential risks for that population, but the data wouldn't be useful for the general public that are younger and/or in better health prior to infection.
    - bhickey 2y ago

zoobab 2y ago

"The FDA (and EMA in Europe) are the only thing that protects desperate patients from fraudsters, charlatans and pharma-companies just looking for a return on their investment." EMA has some people that were recruited from Big Pharma.