My email to Karen at USA Today: Karen Hope
Post# of 154147
(Total Views: 1015)
Posted On: 08/29/2020 9:37:15 PM
My email to Karen at USA Today:
Karen
Hopefully you have nothing else to do and can devote 18 hour days to researching the FDA and their rationale for approving some drugs but not others.
But just in case that isn’t so, here is something that may be of benefit in your limited time available for research.
This should help cement the notion that the FDA is not consistent in their approval process.
Every company whose drug receives an EUA designation from the FDA must also be subject to patient feedback in the event of adverse events (SAE’s).
In fact its a requirement that every SAE be reported to the FDA.
The FDA maintains a public database that captures these events.
I am providing the link for the FDA database for such events.
FDA Adverse Event Reporting System (FAERS) Public Dashboard
Once you click on the link it takes you to the FAERS page - FDA Adverse Event Reporting System.
Click on the button labeled “FAERS Public Dashboard”
Then the disclaimer page- check the box and click ACCEPT
This takes you to the entire FDA Adverse Events Reporting Public Dashboard
In the search box at the top left click the word “search”
That will take you to the search field
Type in Remdesivir
There you will see all the SAE’s for Remdesivir through June 30,2020
Remdesivir was granted the Severe Patient EUA on May 1, 2020.
Reaction Cases reported 1294
Serious cases including deaths. 1025
Death cases 302
You can further granulize the data in the drop down box on the right hand side.
Just selecting “Cases by Reaction” yields a long list of Reactions.
The point in showing this isn’t to say that Remdesivir doesn’t merit an EUA.
Because we don’t know how many patients in total have received the drug.
And this data is only the first two months of the drug’s EUA life.
The point is that this drug does appear to cause adverse reactions. Some quite severe.
And yet we just received news this past week the drug is now given an EUA for Covid Moderate patients.
What of the severe patients? We have 60 days of SAE’s in a public database that aren’t good. What of the July and August SAE’s.
This information should be more transparent to the public and the medical community.
Note: She did acknowledge receiving it and thanked me.
Karen
Hopefully you have nothing else to do and can devote 18 hour days to researching the FDA and their rationale for approving some drugs but not others.
But just in case that isn’t so, here is something that may be of benefit in your limited time available for research.
This should help cement the notion that the FDA is not consistent in their approval process.
Every company whose drug receives an EUA designation from the FDA must also be subject to patient feedback in the event of adverse events (SAE’s).
In fact its a requirement that every SAE be reported to the FDA.
The FDA maintains a public database that captures these events.
I am providing the link for the FDA database for such events.
FDA Adverse Event Reporting System (FAERS) Public Dashboard
Once you click on the link it takes you to the FAERS page - FDA Adverse Event Reporting System.
Click on the button labeled “FAERS Public Dashboard”
Then the disclaimer page- check the box and click ACCEPT
This takes you to the entire FDA Adverse Events Reporting Public Dashboard
In the search box at the top left click the word “search”
That will take you to the search field
Type in Remdesivir
There you will see all the SAE’s for Remdesivir through June 30,2020
Remdesivir was granted the Severe Patient EUA on May 1, 2020.
Reaction Cases reported 1294
Serious cases including deaths. 1025
Death cases 302
You can further granulize the data in the drop down box on the right hand side.
Just selecting “Cases by Reaction” yields a long list of Reactions.
The point in showing this isn’t to say that Remdesivir doesn’t merit an EUA.
Because we don’t know how many patients in total have received the drug.
And this data is only the first two months of the drug’s EUA life.
The point is that this drug does appear to cause adverse reactions. Some quite severe.
And yet we just received news this past week the drug is now given an EUA for Covid Moderate patients.
What of the severe patients? We have 60 days of SAE’s in a public database that aren’t good. What of the July and August SAE’s.
This information should be more transparent to the public and the medical community.
Note: She did acknowledge receiving it and thanked me.
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