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The curious case on Andexxa and why Fauci is full of shite
Posted on 4/4/20 at 8:21 am
Posted on 4/4/20 at 8:21 am
Andexxa is marketed as a reversal agent for eliquis and xarelto, new oral anticoagulants.
The study the drug company used to get it FDA approved has no control arm and the primary outcome was not even a clinical one; it simply used factor Xa level as a surrogate outcome when there are no studies correlating factor Xa level to bleeding resolution.
They literally used basically the same quality of data that we had that generated the hypothesis for hydroxychloroquine use to get their drug FDA approved.
This drug costs THE HOSPITAL 30k-60k a dose depending on how long ago your dose was.
If that shitty level of data was good enough for the FDA to let this drug company peddle their bullshite for tens of thousands of dollars, Fauci can frick right off with his “muh studies”
The study the drug company used to get it FDA approved has no control arm and the primary outcome was not even a clinical one; it simply used factor Xa level as a surrogate outcome when there are no studies correlating factor Xa level to bleeding resolution.
They literally used basically the same quality of data that we had that generated the hypothesis for hydroxychloroquine use to get their drug FDA approved.
This drug costs THE HOSPITAL 30k-60k a dose depending on how long ago your dose was.
If that shitty level of data was good enough for the FDA to let this drug company peddle their bullshite for tens of thousands of dollars, Fauci can frick right off with his “muh studies”
This post was edited on 4/4/20 at 8:22 am
5
Posted on 4/4/20 at 8:23 am to Tiguar
So you’re defaulting towards less rigorous science?
This post was edited on 4/4/20 at 10:05 am
Posted on 4/4/20 at 8:24 am to Tiguar
The FDA is in the bag with Big Pharma. It's all about the $$$ and who gets their hands on it. Keep the elderly over-medicated and prolong their lives (quality of life be damned), and you get to sell more doses. Polypharmacy.
Posted on 4/4/20 at 8:24 am to cwill
I’m wondering why we are perfectly fine with less rigorous science when it lets us charge people 60k to live but when it’s $20 bucks we’re all like “hol up”
Posted on 4/4/20 at 8:27 am to cwill
quote:
So your defaulting towards less rigorous science?
Or, maybe less Bill & Hillary and Bill & Melinda Cronyism
Posted on 4/4/20 at 8:29 am to Tiguar
Jaguar + Tiger = "Mo-Tour" , as in Progressive??
I love your posts too.
I love your posts too.
Posted on 4/4/20 at 8:32 am to TigerMuskyFanMinneso
I have no idea what mo-tour is. I just really hate Andexxa 
Posted on 4/4/20 at 8:35 am to Tiguar
Andexxa was a controversial approval. The clinical reviewers did NOT agree that the risk/benefit threshold was met, and did not agree that surrogate outcome of factor Xa correlates to clinical benefit. The OTAT Director overruled the clinical reviewers so the product was approved under Accelerated Authorization, with a requirement for a post-marketing study with hemostasis as an endpoint.
And you know what? Doctors are smart enough to see the same thing. Sales are NOT where they hoped they'd be. See here: LINK
Reminds me of Xigris. Drug approved for unmet medical need based on one phase 3 study, but all post-marketing trials were failures. The critical care medicine community needed a win, wanted a win, wanted to believe, but come to find out it was not the miracle they hoped for and it was pulled from the market.
Do we really want to see the same thing with covid-19 therapies???
And you know what? Doctors are smart enough to see the same thing. Sales are NOT where they hoped they'd be. See here: LINK
Reminds me of Xigris. Drug approved for unmet medical need based on one phase 3 study, but all post-marketing trials were failures. The critical care medicine community needed a win, wanted a win, wanted to believe, but come to find out it was not the miracle they hoped for and it was pulled from the market.
Do we really want to see the same thing with covid-19 therapies???
This post was edited on 4/4/20 at 8:37 am
Posted on 4/4/20 at 8:37 am to shell01
Their drug reps meet with me all the time. I let them feed me and tell me all the reasons why we need their drug on formulary, why it’s better than kcentra, how great the in vitro studies were.
Then I smile and tell them there is no evidence their drug is any better than tap water and 60k is expensive to participate in their post marketing study.
For some reason they keep bringing me zoeys
Then I smile and tell them there is no evidence their drug is any better than tap water and 60k is expensive to participate in their post marketing study.
For some reason they keep bringing me zoeys
This post was edited on 4/4/20 at 8:45 am
Posted on 4/4/20 at 8:41 am to Tiguar
quote:
For some rest they keep bringing me zoeys
Because you’ll meet with them and they’re justifying their existence with activity.
Posted on 4/4/20 at 8:42 am to the808bass
Suits me. We aren’t ever adding it to formulary
Posted on 4/4/20 at 8:42 am to Tiguar
Why are you still worried about this? The med combo is being used almost everywhere.
Posted on 4/4/20 at 8:43 am to Jake88
Who said anything about being worried?
Posted on 4/4/20 at 9:05 am to Tiguar
You're worried/irritated by what Fauci says, but not many docs are paying attention to him on this as far as I have seen.
Posted on 4/4/20 at 9:09 am to Jake88
I am irritated with Fauci because he’s the face of the governments clinical response to this. I know most physicians are ignoring him and he probably knows it too which makes his continued stance curious.
Posted on 4/4/20 at 9:11 am to cwill
quote:
So your defaulting towards less rigorous science?
I don’t need medicine and science bc I take care of myself, but if there’s a faster way to get you liberal sheep away from this melodrama meltdown handing over your first amendment rights to govt as fast as you can sooner than I’m all for it.
Posted on 4/4/20 at 9:21 am to Tiguar
As others have said, we carry it, never use it. The opposition to it from experts in the field is pretty broad. I can understand why it was rushed through since the Xa meds have bad outcomes for GIBs and hemorrhagic strokes because of poorly controlled bleeding as a last resort. Not saying it’s right, but when the standard of care fails it’s nice to have a Hail Mary
Posted on 4/4/20 at 9:52 am to WylieTiger
quote:
The FDA is in the bag with Big Pharma. It's all about the $$$ and who gets their hands on it.
You can't trust an organization that is paid to keep non-patentable medicines off the market.
Posted on 4/4/20 at 10:07 am to Tiguar
quote:
I’m wondering why we are perfectly fine with less rigorous science when it lets us charge people 60k to live but when it’s $20 bucks we’re all like “hol up”
Are doctors not allowed to prescribe/use hydroxychloriquine or are they just saying it’s effectiveness is not proven scientifically?
Posted on 4/4/20 at 10:11 am to Andychapman13
quote:
I don’t need medicine and science bc I take care of myself,
Let me guess, you handle snakes....pray away cancer or appendicitis?
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