Could you share more about that malpractice case (as much as you can legally disclose) and elaborate on what you learned about the rules governing EUAs?
Could you share more about that malpractice case (as much as you can legally disclose) and elaborate on what you learned about the rules governing EUAs?
Below is what is relevant, based on my best recollection from yeas ago, as it relates to the patient. 5 major tenets govern the use of an EUA approved drug/device. These are still valid and part of the rules/process today.
1. Full informed consent, in writing, in language a person not in the medical field can understand.
2. Complete list of possible adverse reactions, including clinical trial data showing raw numbers and percentages.
3. Additional list of possible adverse reactions not seen during clinical trials but possible due to data from other sources (ex: animal trials).
4. No incentive, no coercion, no mandate, no demand, can be used to convince the patient. (The no incentive also applies to the medical side).
5. No EUA can ever be given to anyone under the age of 18, without the parent/legal guardian consent.
They broke every rule. In addition, based on the law and the rules that were in place 15 years ago, every private company that offered an incentive broke the law, and every person in the medical field who took payment above their ‘normal’ rate broke the law.
It’s possible changes in the law were made. I don’t know. I am very confident that #1-5 above are all still valid.
Remdesivir was also authorized to treat Covid via an EUA. And we know hospitals were given massive incentives for its use.
My wife was hospitalized with double pneumonia in November 2021. Of course she tested positive for Covid at 45 cycles. But Covid wasn’t the issue. She has Medicare and a Part G supplement. We never got any bills. Never got any statements from Medicar. Never got any bills or statements from the Part G carrier. They just made it all disappear.
I am now trying to extract her medical records and test results from the hospital. They don’t want to give them up, which is interesting but not surprising. (She did get outstanding care and was released after 72 hours).
Lastly, the way they got away with all of it is because of the PREP Act and because it was all a DOD operation. They just completely ignored 75 years of history because they could.
Following from Wikipedia. I don’t think the links will show up. But there are links in the summary to the various laws
Hope I answered your question. Have a nice weekend. Eric
In the United States, EUAs are authorized by Section 564 of the Federal Food Drug and Cosmetic Act (FDCA) of 1938 (Public Law 75-717) as added and subsequently amended by the Project BioShield Act of 2004 (S. 15, Public Law 108–276) for funding of the development and procurement of medical countermeasures against CBRN threats, the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307, Pub. L.Tooltip Public Law (United States) 113–5 (text) (PDF)), the 21st Century Cures Act of 2016 (H.R. 34, Public Law 114–255) and Pub. L.Tooltip Public Law (United States) 115–92 (text) (PDF) of 2017 (no short title).
Could you share more about that malpractice case (as much as you can legally disclose) and elaborate on what you learned about the rules governing EUAs?
Below is what is relevant, based on my best recollection from yeas ago, as it relates to the patient. 5 major tenets govern the use of an EUA approved drug/device. These are still valid and part of the rules/process today.
1. Full informed consent, in writing, in language a person not in the medical field can understand.
2. Complete list of possible adverse reactions, including clinical trial data showing raw numbers and percentages.
3. Additional list of possible adverse reactions not seen during clinical trials but possible due to data from other sources (ex: animal trials).
4. No incentive, no coercion, no mandate, no demand, can be used to convince the patient. (The no incentive also applies to the medical side).
5. No EUA can ever be given to anyone under the age of 18, without the parent/legal guardian consent.
They broke every rule. In addition, based on the law and the rules that were in place 15 years ago, every private company that offered an incentive broke the law, and every person in the medical field who took payment above their ‘normal’ rate broke the law.
It’s possible changes in the law were made. I don’t know. I am very confident that #1-5 above are all still valid.
Remdesivir was also authorized to treat Covid via an EUA. And we know hospitals were given massive incentives for its use.
My wife was hospitalized with double pneumonia in November 2021. Of course she tested positive for Covid at 45 cycles. But Covid wasn’t the issue. She has Medicare and a Part G supplement. We never got any bills. Never got any statements from Medicar. Never got any bills or statements from the Part G carrier. They just made it all disappear.
I am now trying to extract her medical records and test results from the hospital. They don’t want to give them up, which is interesting but not surprising. (She did get outstanding care and was released after 72 hours).
Lastly, the way they got away with all of it is because of the PREP Act and because it was all a DOD operation. They just completely ignored 75 years of history because they could.
Following from Wikipedia. I don’t think the links will show up. But there are links in the summary to the various laws
Hope I answered your question. Have a nice weekend. Eric
In the United States, EUAs are authorized by Section 564 of the Federal Food Drug and Cosmetic Act (FDCA) of 1938 (Public Law 75-717) as added and subsequently amended by the Project BioShield Act of 2004 (S. 15, Public Law 108–276) for funding of the development and procurement of medical countermeasures against CBRN threats, the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307, Pub. L.Tooltip Public Law (United States) 113–5 (text) (PDF)), the 21st Century Cures Act of 2016 (H.R. 34, Public Law 114–255) and Pub. L.Tooltip Public Law (United States) 115–92 (text) (PDF) of 2017 (no short title).