4 ms·

It is you who is mistaken. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency

It is you who is mistaken. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

nradov 5y ago
No I have it exactly right and you still don't understand the law. The FDA has wide latitude in how they interpret the word "adequate". And while it's possible that ivermectin may prove effective for COVID-19 treatment, as of today it's still not formally "approved" for that use. Doctors can prescribe it to COVID-19 patients but it's considered off-label use.
- yeuxardents 5y ago
  Except you are still dancing around the topic here. The OP being responded to here, which is clearly widely available if you pay any attention to the news, is that the mainstream, FDA, CDC and pharma companies are seeking to extremely downplay, or outright declare ivermectin to be out of line, without doing any research, AND ignoring already existing clinical studies that show it to be efficacious. Thats the conversation, not splitting hairs on what is or is not adequate. FDA won't even seem to bother EVALUATING if it IS in fact adequate. Instead these players are acting like it does not exist, or is deadly, when it has a 30+ year history of clearly not being so. Edit: Hence my point about the billions of dollars in loss. Were the FDA to declare ivermectin efficacious and adequate then the EUA's would likely have to be rescinded. If not, then people would still have an alternative treatment to the vaccines, and thus pharma would lose billions to alternative treatment anyway. Option: Take 30+ year medicine with proven track record or take experimental vaccines that have not completed FDA approval or clinical trials, no cross sectional longitudinal studies of effects? https://www.law.cornell.edu/uscode/text/21/360bbb-3 https://www.law.cornell.edu/uscode/text/21/360bbb-3
  - nradov 5y ago
    Apparently you haven't been paying attention. The federal government is sponsoring research. The scientific method is not instantaneous. Have a little patience. https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trials https://www.nih.gov/research-training/medical-research-initi...
    - yeuxardents 5y ago
      I AM aware of it, but youre still tap dancing, which leads me to understand you are not having this conversation in good faith. Goodbye.
  - belltaco 5y ago
    Ivermectin isn't a magic cure for covid or there wouldn't be so many trials showing it doesn't work. Even if future studies prove its useful the effect size is small. So other mitigation efforts will continue. And Pfizer is already fully approved btw.
dragonwriter 5y ago
Even if Ivermectin were established as adequate in its conjectured/hyped/potential COVID-related role, it and vaccines would not be alternatives, since they don't substitute for each other. Some of the monoclonal antibody treatments under EUA would be closer to being at risk.

nradov 5y ago

No I have it exactly right and you still don't understand the law. The FDA has wide latitude in how they interpret the word "adequate". And while it's possible that ivermectin may prove effective for COVID-19 treatment, as of today it's still not formally "approved" for that use. Doctors can prescribe it to COVID-19 patients but it's considered off-label use.

yeuxardents 5y ago
Except you are still dancing around the topic here. The OP being responded to here, which is clearly widely available if you pay any attention to the news, is that the mainstream, FDA, CDC and pharma companies are seeking to extremely downplay, or outright declare ivermectin to be out of line, without doing any research, AND ignoring already existing clinical studies that show it to be efficacious. Thats the conversation, not splitting hairs on what is or is not adequate. FDA won't even seem to bother EVALUATING if it IS in fact adequate. Instead these players are acting like it does not exist, or is deadly, when it has a 30+ year history of clearly not being so. Edit: Hence my point about the billions of dollars in loss. Were the FDA to declare ivermectin efficacious and adequate then the EUA's would likely have to be rescinded. If not, then people would still have an alternative treatment to the vaccines, and thus pharma would lose billions to alternative treatment anyway. Option: Take 30+ year medicine with proven track record or take experimental vaccines that have not completed FDA approval or clinical trials, no cross sectional longitudinal studies of effects? https://www.law.cornell.edu/uscode/text/21/360bbb-3 https://www.law.cornell.edu/uscode/text/21/360bbb-3
- nradov 5y ago
  Apparently you haven't been paying attention. The federal government is sponsoring research. The scientific method is not instantaneous. Have a little patience. https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trials https://www.nih.gov/research-training/medical-research-initi...
  - yeuxardents 5y ago
    I AM aware of it, but youre still tap dancing, which leads me to understand you are not having this conversation in good faith. Goodbye.
- belltaco 5y ago
  Ivermectin isn't a magic cure for covid or there wouldn't be so many trials showing it doesn't work. Even if future studies prove its useful the effect size is small. So other mitigation efforts will continue. And Pfizer is already fully approved btw.

dragonwriter 5y ago

Even if Ivermectin were established as adequate in its conjectured/hyped/potential COVID-related role, it and vaccines would not be alternatives, since they don't substitute for each other. Some of the monoclonal antibody treatments under EUA would be closer to being at risk.