Posted on Apr 8, 2023
'Ridiculous claim': Doctor destroys Trump judge's ruling axing abortion drug
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"I just want to ask you ... the judge in the case was saying that one of the things the FDA has not taken into account enough is the psychological effect that taking this drug has on women," said Cooper. "This drug has been around now for some two decades. Is there proof of that? I mean, is what he said accurate?"
"No, not at all," said Conti. "And I mean, I think you can tell from my eye rolling, that's a ridiculous claim. We've got over 20 years of collected data with millions of women who use this medication, millions of people who have used it, and also lots of really good research."
"No, not at all," said Conti. "And I mean, I think you can tell from my eye rolling, that's a ridiculous claim. We've got over 20 years of collected data with millions of women who use this medication, millions of people who have used it, and also lots of really good research."
'Ridiculous claim': Doctor destroys Trump judge's ruling axing abortion drug
Posted from rawstory.com
Abortion
Medical
Health
Drugs
Pharmaceuticals
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PO1 William "Chip" Nagel good day Brother William, always informational and of the most interesting. Thanks for sharing, have a blessed day!
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(note added up top after reading, reading and reading ... I guess some other headline could read "FDA attempts to classify pregnancy as an illness")
I was curious about the article's claims that the article heavily suggests is that the core principle for the Judge's ruling was the "psychological effect that taking this drug has on women" when the standing of the plaintiffs was being reviewed - not the basis of the lawsuit. I looked up the text of the ruling.* Yes ... my eyes glazed over for the most of it... as exciting to read as the phone book (if you remember what one of those was).
The central theme of the ruling deals with the lack of clinical research prior to approval (the 'mental health' aspect is mentioned as an "additional factor" on page 10 of the ruling), that the approval was done incorrectly and that this case should have been heard decades ago if not for the FDA violating federal law on responses to the timeliness of responding to a challenge/petition. The fact that the drug apparently never went though full approval and instead went through accelerated approval was key.
I was still curious about adverse affects of mifepristone so looked up any NIH articles about it. According to "Deaths and Severe Adverse Events after the use of Mifepristone as an Abortifacient from September 2000 to February 2019"*, there were 3197 unique US-only adverse events (AEs) reported (side note: the FDA stopped mandatory reporting of AEs in 2016) of which 2660 were looked at because 537 of them didn't have sufficient information to determine severity. Of these, 94% were classified as causing death or were life-threatening (20%), or had a severe reaction (74%).
I have no idea about the widespread use of mifepristone or if 2,500 severe/life-threatening/death events over a 20 year period (average of 125 events a year ... 26 of them being death) is considered a lot or not.
I looked at other drugs that have been pulled from the market and what the threshold was regarding how/when they were pulled. On the high side, Vioxx (pain-relieving medication) was pulled from the market back in 2004 and that was after 'thousands of deaths may have been caused' by it (unknown how many were actually caused by it). On the low side, Duract (NSAID to treat pain and inflammation) was recalled in 1998 because of liver damage and causing the deaths of between 5 and 10 patients because of liver failure. The other 'high vis drugs' that were pulled (Redux (dexfenfluramine), Propulsid (cisapride), and Zelnorm (tegaserod)) ranged between 13 deaths and 100 deaths before they were pulled.
According to the lawsuit, the FDA categorized pregnancy as an illness when it evaluated the drug's safety instead of a 'convenience drug' (the section the FDA used to approve the drug which places adverse effects in context to the illness they are treating). The approval process (the "Final Rule") used by the FDA could also be used for "conditions that are serious or life-threatening" if they aren't classified as illnesses.
Where the psychological effect on women WAS discussed was brought up by the FDA - they said that "approximately fifty percent of pregnancies in the United States are unintended and that unintended pregnancies may cause depression and anxiety". The judge dismissed that argument because "categorizing complications or negative psychological experiences arising FROM pregnancy as illnesses is materially different than classifying pregnancy itself as a serious or life-threatening illness per se". According to the Judge, by the FDA's reasoning, anything could than be used for accelerated approval instead of full approval. The example was that if someone experienced depression because of lower-back pain that inhibits her mobility that the FDA could use the accelerated approval process on a drug to treat lower back pain.
This seems to be a case where there is wrong on the FDA's side .. but is it 'wrong enough' to take a drug off the market that's been in use for 20 years? There are an AVERAGE of 26.6 instances each year that are life-threatening or where someone died from it (20% of the 2660 AERs over a 20 year period = 26.6) - is this enough to cause it to be pulled pending a full approval process?
I for one have no clue.
---------------------------------------------
* https://int.nyt.com/data/documenttools/court-decision-invalidating-approval-of-mifepristone/0bb045930a649567/full.pdf
* https://pubmed.ncbi.nlm.nih.gov/33939340/
I was curious about the article's claims that the article heavily suggests is that the core principle for the Judge's ruling was the "psychological effect that taking this drug has on women" when the standing of the plaintiffs was being reviewed - not the basis of the lawsuit. I looked up the text of the ruling.* Yes ... my eyes glazed over for the most of it... as exciting to read as the phone book (if you remember what one of those was).
The central theme of the ruling deals with the lack of clinical research prior to approval (the 'mental health' aspect is mentioned as an "additional factor" on page 10 of the ruling), that the approval was done incorrectly and that this case should have been heard decades ago if not for the FDA violating federal law on responses to the timeliness of responding to a challenge/petition. The fact that the drug apparently never went though full approval and instead went through accelerated approval was key.
I was still curious about adverse affects of mifepristone so looked up any NIH articles about it. According to "Deaths and Severe Adverse Events after the use of Mifepristone as an Abortifacient from September 2000 to February 2019"*, there were 3197 unique US-only adverse events (AEs) reported (side note: the FDA stopped mandatory reporting of AEs in 2016) of which 2660 were looked at because 537 of them didn't have sufficient information to determine severity. Of these, 94% were classified as causing death or were life-threatening (20%), or had a severe reaction (74%).
I have no idea about the widespread use of mifepristone or if 2,500 severe/life-threatening/death events over a 20 year period (average of 125 events a year ... 26 of them being death) is considered a lot or not.
I looked at other drugs that have been pulled from the market and what the threshold was regarding how/when they were pulled. On the high side, Vioxx (pain-relieving medication) was pulled from the market back in 2004 and that was after 'thousands of deaths may have been caused' by it (unknown how many were actually caused by it). On the low side, Duract (NSAID to treat pain and inflammation) was recalled in 1998 because of liver damage and causing the deaths of between 5 and 10 patients because of liver failure. The other 'high vis drugs' that were pulled (Redux (dexfenfluramine), Propulsid (cisapride), and Zelnorm (tegaserod)) ranged between 13 deaths and 100 deaths before they were pulled.
According to the lawsuit, the FDA categorized pregnancy as an illness when it evaluated the drug's safety instead of a 'convenience drug' (the section the FDA used to approve the drug which places adverse effects in context to the illness they are treating). The approval process (the "Final Rule") used by the FDA could also be used for "conditions that are serious or life-threatening" if they aren't classified as illnesses.
Where the psychological effect on women WAS discussed was brought up by the FDA - they said that "approximately fifty percent of pregnancies in the United States are unintended and that unintended pregnancies may cause depression and anxiety". The judge dismissed that argument because "categorizing complications or negative psychological experiences arising FROM pregnancy as illnesses is materially different than classifying pregnancy itself as a serious or life-threatening illness per se". According to the Judge, by the FDA's reasoning, anything could than be used for accelerated approval instead of full approval. The example was that if someone experienced depression because of lower-back pain that inhibits her mobility that the FDA could use the accelerated approval process on a drug to treat lower back pain.
This seems to be a case where there is wrong on the FDA's side .. but is it 'wrong enough' to take a drug off the market that's been in use for 20 years? There are an AVERAGE of 26.6 instances each year that are life-threatening or where someone died from it (20% of the 2660 AERs over a 20 year period = 26.6) - is this enough to cause it to be pulled pending a full approval process?
I for one have no clue.
---------------------------------------------
* https://int.nyt.com/data/documenttools/court-decision-invalidating-approval-of-mifepristone/0bb045930a649567/full.pdf
* https://pubmed.ncbi.nlm.nih.gov/33939340/
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