Monoclonal Antibodies and FDA Emergency Use

 

Since again the “news” media do such a terrible job of reporting facts, I’m turning to the knowledgeable people of Ricochet.

Is the monoclonal antibody treatment for which the Food and Drug Administration recently revoked emergency-use authorization the only monoclonal antibody treatment that was available to the public? In other words, did the FDA’s revocation stop all monoclonal antibody treatments for people who get COVID-19 or only some? The news media is interested only in reporting the politicians yelling at each other, not on any underlying facts.

I had been hearing many anecdotal stories about favorable results from monoclonal antibody treatments. Among the anecdotes, two friends of mine who recently (two weeks ago) tested positive for COVID-19 received monoclonal antibody treatments, and their conditions immediately improved significantly. Of course, the experience of two of my friends is not scientific proof of anything, and we can’t even be certain that the treatment caused the improvement of my two friends — though for one in particular, the coincidence of treatment and the magnitude of improvement was remarkable. Nor do I know if their treatments were the same ones for which the FDA revoked emergency-use authorization.

The closing of Florida treatment centers and accompanying yelling by Florida Gov. Ron DeSantis gives the impression that all monoclonal antibody treatments have been stopped. But maybe Florida was using only one version, the version that was the subject of the FDA action.

I admit that I come into this discussion with a bias, as it seems to me that the FDA and the Centers for Disease Control and Prevention are focused on vaccines for COVID-19 and are generally opposed to (or at least uninterested in) finding treatments for those who become infected. That anti-treatment bias may not be true, but abruptly revoking the emergency-use authorization of monoclonal antibodies without much further detailed explanation provides fuel for the speculation that the agencies are anti-treatment. More information on the scope of the FDA’s action would help the not-medically-trained me evaluate what’s going on.

So, did the FDA’s revocation of emergency-use authorization for monoclonal antibody treatments apply to only some treatments or to all of the monoclonal antibody treatments that people had been getting? Do people who have COVID-19 still have an option to receive monoclonal antibody treatment, or are all options to receive monoclonal antibody treatment off the table?

Published in Healthcare
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There are 54 comments.

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  1. Kozak Member
    Kozak
    @Kozak

    The issue is that the FDA has decided that current monoclonal antibody treatment is not effective against the Omicron variant. Both Regeneron and the Lilly version were removed from the NIH guidelines. The Glaxo version is still recommended.

    “Because Omicron has become the dominant VOC in the United States and real-time testing to identify rare, non-Omicron variants is not routinely available, the Panel recommends against using bamlanivimab plus etesevimab or casirivimab plus imdevimab (AIII),” said the updated NIH guidelines, published Wednesday.

    “NIH is still recommending the use of GlaxoSmithKline’s monoclonal antibody, sotrovimab, as a single IV infusion administered as soon as it can be within 10 days of symptoms appearing for those over the age of 12.”

    “The Omicron VOC has become the dominant variant in the United States and is predicted to have markedly reduced susceptibility to bamlanivimab plus etesevimab and casirivimab plus imdevimab,” said the NIH statement. “In vitro studies indicate that sotrovimab remains active against the Omicron VOC.”

    This is terrible news because the monoclonal antibody therapy had shown to be very effective at limiting the severity of symptoms from those who developed covid.   The logical fallacy here is although Omicron is the dominant strain in the US, it’s not the only strain out there.   Since there is no way to know clinically which strain it is,  I would think it would make sense to continue to treat those at high risk or who are showing severe symptoms from Covid.

    • #1
  2. MarciN Member
    MarciN
    @MarciN

    Kozak (View Comment):
    “is predicted to have markedly reduced susceptibility to bamlanivimab plus etesevimab and casirivimab plus imdevimab,”

    Few sentences have left me more aware of the enormity of my ignorance than that one. :-) :-)

    I used to be able to work out word meanings from Latin and Greek prefixes and suffixes. I’m not even in the guessing range on these. :-)

    • #2
  3. DonG (CAGW is a hoax) Coolidge
    DonG (CAGW is a hoax)
    @DonG

    Kozak (View Comment):
    Since there is no way to know clinically which strain it is,  I would think it would make sense to continue to treat those at high risk or who are showing severe symptoms from Covid.

    Yes!  The FDA has gone crazy with its all-or-nothing mindset applied to 330 million individuals.   As for “no way to know clinically”, I would think the symptoms would make it clear if the infection was upper or lower respiratory centered, which is good enough to choose monoclonal antibodies.  I think doctors still use stethoscopes;)

    As for Florida, it is a 40 minute boat ride to be in international waters.  I expect some enterprising casino cruise business to add Covid Treatments.  Blackjack, craps and Ivermectin here!

    • #3
  4. Unsk Member
    Unsk
    @Unsk

    This decision by the FDA was clearly based  on politics not science.   It is an outrage. An Atrocity. 

    • #4
  5. Kozak Member
    Kozak
    @Kozak

    DonG (CAGW is a hoax) (View Comment):

    Kozak (View Comment):
    Since there is no way to know clinically which strain it is, I would think it would make sense to continue to treat those at high risk or who are showing severe symptoms from Covid.

    Yes! The FDA has gone crazy with its all-or-nothing mindset applied to 330 million individuals. As for “no way to know clinically”, I would think the symptoms would make it clear if the infection was upper or lower respiratory centered, which is good enough to choose monoclonal antibodies. I think doctors still use stethoscopes;)

    As for Florida, it is a 40 minute boat ride to be in international waters. I expect some enterprising casino cruise business to add Covid Treatments. Blackjack, craps and Ivermectin here!

    I meant that if you test positive for Covid there is no way for the clinician to tell which variant it is.   If we had a rapid way to determine that it would be a useful tool to council the patient and guide therapy.  “ you have delta,  you are at higher risk for more severe illness, and monoclonal antibody therapy may be very helpful”.   “ you have Omicron.  Most likely will have mild symptoms and monoclonal antibody therapy is not likely to help.”

    • #5
  6. EJHill Podcaster
    EJHill
    @EJHill

    What Kozak said. The only way to know what variant of Covid you have contracted is to sequence the genome of the virus. We do that in less than 1% of all cases in the United States and it takes an average of 28 days to get the results. Basically, the FDA just signed the death warrants for a lot of people. It is insanity. Monoclonal treatments probably saved my daughter’s life.

    • #6
  7. Kozak Member
    Kozak
    @Kozak

    MarciN (View Comment):

    Kozak (View Comment):
    “is predicted to have markedly reduced susceptibility to bamlanivimab plus etesevimab and casirivimab plus imdevimab,”

    Few sentences have left me more aware of the enormity of my ignorance than that one. :-) :-)

    I used to be able to work out word meanings from Latin and Greek prefixes and suffixes. I’m not even in the guessing range on these. :-)

    Any medicine that ends in “mab” is an antibody fragment.

    • #7
  8. DrewInWisconsin, Oaf Member
    DrewInWisconsin, Oaf
    @DrewInWisconsin

    EJHill (View Comment):
    Basically, the FDA just signed the death warrants for a lot of people.

    And will suffer no consequences. And that’s the hell of it.

    • #8
  9. Dr. Bastiat Member
    Dr. Bastiat
    @drbastiat

    Kozak (View Comment):
    This is terrible news because the monoclonal antibody therapy had shown to be very effective at limiting the severity of symptoms from those who developed covid.   The logical fallacy here is although Omicron is the dominant strain in the US, it’s not the only strain out there.   Since there is no way to know clinically which strain it is,  I would think it would make sense to continue to treat those at high risk or who are showing severe symptoms from Covid.

    If someone gets COVID and gets really sick, I presume it’s not Omicron.  

    Hard to say for sure, of course…

    • #9
  10. Full Size Tabby Member
    Full Size Tabby
    @FullSizeTabby

    To continue to try to understand a little more the FDA, but if the treatment truly is not useful against the Omicron variant, AND the Omicron variant is (as I have read) 99% of the Covid out there, then maybe the FDA is logical in withdrawing emergency use authorization for something that’s only useful in a tiny percentage of cases?

    [As a non-medically-trained person I am baffled that variants of the same virus behave so differently that treatments can have such radically different effectiveness, but that’s probably a different topic.] 

    • #10
  11. EJHill Podcaster
    EJHill
    @EJHill

    Nine out of the last 10 FDA Commissioners now draw a paycheck from a pharmaceutical company. I’m sure that’s just a coincidence.

    • #11
  12. DrewInWisconsin, Oaf Member
    DrewInWisconsin, Oaf
    @DrewInWisconsin

    As noted elsewhere, if monoclonal antibody treatments don’t work, then why are they trying to deny them to white people? The logical answers do not speak well of our ruling class.

    • #12
  13. Scott Wilmot Member
    Scott Wilmot
    @ScottWilmot

    Maybe one day we can have vaccines and treatments that don’t sacrifice our children for the testing and production of same. There is a lot of money exchanged between the pharmaceutical and abortion industries. To our shame, we let this continue. May God have mercy on us.

    • #13
  14. Flicker Coolidge
    Flicker
    @Flicker

    DonG (CAGW is a hoax) (View Comment):

    As for Florida, it is a 40 minute boat ride to be in international waters.  I expect some enterprising casino cruise business to add Covid Treatments.  Blackjack, craps and Ivermectin here!

    Isn’t it against the law to travel out of the country for the purpose of committing a crime such as child prostitution or taking a covid therapeutic??

    • #14
  15. Kozak Member
    Kozak
    @Kozak

    Dr. Bastiat (View Comment):

    Kozak (View Comment):
    This is terrible news because the monoclonal antibody therapy had shown to be very effective at limiting the severity of symptoms from those who developed covid. The logical fallacy here is although Omicron is the dominant strain in the US, it’s not the only strain out there. Since there is no way to know clinically which strain it is, I would think it would make sense to continue to treat those at high risk or who are showing severe symptoms from Covid.

    If someone gets COVID and gets really sick, I presume it’s not Omicron.

    Hard to say for sure, of course…

    Yeah I feel the same way.  And I don’t see the harm of using MC antibodies in that case. 

    • #15
  16. Dr. Bastiat Member
    Dr. Bastiat
    @drbastiat

    Kozak (View Comment):

    Dr. Bastiat (View Comment):

    Kozak (View Comment):
    This is terrible news because the monoclonal antibody therapy had shown to be very effective at limiting the severity of symptoms from those who developed covid. The logical fallacy here is although Omicron is the dominant strain in the US, it’s not the only strain out there. Since there is no way to know clinically which strain it is, I would think it would make sense to continue to treat those at high risk or who are showing severe symptoms from Covid.

    If someone gets COVID and gets really sick, I presume it’s not Omicron.

    Hard to say for sure, of course…

    Yeah I feel the same way. And I don’t see the harm of using MC antibodies in that case.

    Exactly.

    • #16
  17. Flicker Coolidge
    Flicker
    @Flicker

    Dr. Bastiat (View Comment):

    Kozak (View Comment):

    Dr. Bastiat (View Comment):

    Kozak (View Comment):
    This is terrible news because the monoclonal antibody therapy had shown to be very effective at limiting the severity of symptoms from those who developed covid. The logical fallacy here is although Omicron is the dominant strain in the US, it’s not the only strain out there. Since there is no way to know clinically which strain it is, I would think it would make sense to continue to treat those at high risk or who are showing severe symptoms from Covid.

    If someone gets COVID and gets really sick, I presume it’s not Omicron.

    Hard to say for sure, of course…

    Yeah I feel the same way. And I don’t see the harm of using MC antibodies in that case.

    Exactly.

    Isn’t this just another step in removing all therapeutics.

    • #17
  18. The Reticulator Member
    The Reticulator
    @TheReticulator

    Flicker (View Comment):

    Dr. Bastiat (View Comment):

    Kozak (View Comment):

    Dr. Bastiat (View Comment):

    Kozak (View Comment):
    This is terrible news because the monoclonal antibody therapy had shown to be very effective at limiting the severity of symptoms from those who developed covid. The logical fallacy here is although Omicron is the dominant strain in the US, it’s not the only strain out there. Since there is no way to know clinically which strain it is, I would think it would make sense to continue to treat those at high risk or who are showing severe symptoms from Covid.

    If someone gets COVID and gets really sick, I presume it’s not Omicron.

    Hard to say for sure, of course…

    Yeah I feel the same way. And I don’t see the harm of using MC antibodies in that case.

    Exactly.

    Isn’t this just another step in removing all therapeutics.

     If that was the case, they wouldn’t have given emergency authorization for PAXLOVID, would they? The problem with that one is it will take a while to fill up the supply chain. 

    • #18
  19. Flicker Coolidge
    Flicker
    @Flicker

    The Reticulator (View Comment):

    Flicker (View Comment):

    Dr. Bastiat (View Comment):

    Kozak (View Comment):

    Dr. Bastiat (View Comment):

    Kozak (View Comment):
    This is terrible news because the monoclonal antibody therapy had shown to be very effective at limiting the severity of symptoms from those who developed covid. The logical fallacy here is although Omicron is the dominant strain in the US, it’s not the only strain out there. Since there is no way to know clinically which strain it is, I would think it would make sense to continue to treat those at high risk or who are showing severe symptoms from Covid.

    If someone gets COVID and gets really sick, I presume it’s not Omicron.

    Hard to say for sure, of course…

    Yeah I feel the same way. And I don’t see the harm of using MC antibodies in that case.

    Exactly.

    Isn’t this just another step in removing all therapeutics.

    If that was the case, they wouldn’t have given emergency authorization for PAXLOVID, would they? The problem with that one is it will take a while to fill up the supply chain.

    I thought of that.  Hasn’t the government already bought up and stockpiled all the monoclonal antibodies?  Paxlovid is the next money maker.

    • #19
  20. The Reticulator Member
    The Reticulator
    @TheReticulator

    Flicker (View Comment):

    Isn’t this just another step in removing all therapeutics.

    If that was the case, they wouldn’t have given emergency authorization for PAXLOVID, would they? The problem with that one is it will take a while to fill up the supply chain.

    I thought of that.  Hasn’t the government already bought up and stockpiled all the monoclonal antibodies?

    I don’t know. It’s sort of possible, I suppose. I blame Biden for the antigen test shortage because of his government purchases messing up the market.  But I have heard nothing about its buying monoclonal antibodies.  That one of the three antibody treatments is still effective against Omicron, so is in very short supply, but I haven’t heard that it’s not being used. It’s just that there’s not enough to go around. But if you have information showing the government messed with the market, I’m interested. 

      Paxlovid is the next money maker.

    I hope so. I hope they ramp up production and make a ton of money saving people’s lives and reducing the severity of the disease. 

    • #20
  21. DrewInWisconsin, Oaf Member
    DrewInWisconsin, Oaf
    @DrewInWisconsin

    The problem is that the Biden administration never really bothered to invest in the production of monoclonal antibodies, creating a shortage last fall when the Biden administration took over distribution of them. Previously, states and hospitals ordered up the treatments direct. The federal government stepped in and took over. Then instead of direct supply to states that had higher case loads, they decided to go for “equity,” meaning that Florida and Texas (two very populous states that had higher case loads at the time) didn’t get what they needed. Government-created shortage, government-created rationing (for equity!), government-created crisis.

    • #21
  22. Vance Richards Member
    Vance Richards
    @VanceRichards

    So, not effective against Omicron is based on something other than tests done by competitors?

    Omnicrom is the most prevalent, but not the only variant. So, these treatments could still help some, right? Are there serious side-effects? Why ban something that could help certain people?

    The White House is big on pushing vaccines. But this isn’t an either or proposition. Having more treatment options isn’t a bad thing, is it?

    • #22
  23. The Reticulator Member
    The Reticulator
    @TheReticulator

    Vance Richards (View Comment):

    So, not effective against Omicron is based on something other than tests done by competitors?

    Omnicrom is the most prevalent, but not the only variant. So, these treatments could still help some, right? Are there serious side-effects? Why ban something that could help certain people?

    Certain types of people are big on bans and mandates.  If they can’t ban or mandate this, they’ll have to ban or mandate something else in order to feel fulfilled.  

    It would be good for doctors to know that two of the three monoclonals are not likely to help anymore now that almost all infections are Omicron, but a ban is a stupid way to accomplish that.  

    One side effect of monoclonals is that they are expensive and use up considerable medical resources. So, maybe the government figures that a ban is a way to conserve the resources needed for herd management (where we are the herd). That sort of thing is one of the side effects of nationalized health care.

    The White House is big on pushing vaccines. But this isn’t an either or proposition. Having more treatment options isn’t a bad thing, is it?

     

    • #23
  24. DrewInWisconsin, Oaf Member
    DrewInWisconsin, Oaf
    @DrewInWisconsin

    Vance Richards (View Comment):
    The White House is big on pushing vaccines. But this isn’t an either or proposition. Having more treatment options isn’t a bad thing, is it?

    Your refusal to endorse the vax-only solution could harm real billionaires with multiple yachts.

    • #24
  25. Full Size Tabby Member
    Full Size Tabby
    @FullSizeTabby

    Vance Richards (View Comment):

    So, not effective against Omicron is based on something other than tests done by competitors?

    Omnicrom is the most prevalent, but not the only variant. So, these treatments could still help some, right? Are there serious side-effects? Why ban something that could help certain people?

    The White House is big on pushing vaccines. But this isn’t an either or proposition. Having more treatment options isn’t a bad thing, is it?

    This is part of my motivation for asking for facts – the cancelation of the emergency use authorization seems to reinforce the appearance that the federal government is constricting treatments as part of a campaign to make the vaccine the exclusive answer to Covid.

    • #25
  26. Caryn Thatcher
    Caryn
    @Caryn

    EJHill (View Comment):

    What Kozak said. The only way to know what variant of Covid you have contracted is to sequence the genome of the virus. We do that in less than 1% of all cases in the United States and it takes an average of 28 days to get the results. Basically, the FDA just signed the death warrants for a lot of people. It is insanity. Monoclonal treatments probably saved my daughter’s life.

    We’re sequencing in-house in essentially real-time.  We have a weekly sampling of at least a couple hundred randomly selected patient samples that are sequenced and reported daily–we get a weekly cumulative report on Monday, which includes the previous week through Friday, to all interested parties in our hospital system.  Locally, we’re at about 97% omicron after being around 98-99% delta for several months.  The change was extremely rapid and took place over the course of 2-3 weeks.  Pretty stunning curves (that I can’t share, unfortunately). Delta had a similar explosion and rapid expansion of cases, but lasted longer.  This one has had a pretty precipitous decline.  Let’s see what happens next… One nice thing is that I’m not hearing of an emerging variant.  Non-omicron, at least here, is still delta.

    PS: I agree with “What Kozak said.”  Despite omicron being dominant, those other monoclonals should be available for the other strains.  What I don’t know, and perhaps Kozak can answer, is whether use of sotrovimab precludes use of the others.  If sotrovimab has broader coverage–ie. is still effective against the other strains–that might be fine, if supply is adequate.  Adequate supply remains a question, particularly if the Federal government is involved in distribution.  In general, I think all proven therapies should remain in the armamentarium. It’s short-sighted to pull their approvals and availabilities.

    • #26
  27. Caryn Thatcher
    Caryn
    @Caryn

    Full Size Tabby (View Comment):

    <snip>

    [As a non-medically-trained person I am baffled that variants of the same virus behave so differently that treatments can have such radically different effectiveness, but that’s probably a different topic.]

    This is not unusual and is very common in bacteria that have multiple serotypes (Streptococcus pneumoniae, for example, which has over 90 distinct serotypes).  Anything that mutates (and particularly bacteria that live in mixed “housing” as it were and occasionally exchange genetic information with “neighbors”) has the ability to acquire or develop virulence factors and intrinsic resistance strain by strain.  The parenthetically mentioned S. pneumoniae has serotypes that are relatively benign and others that have high levels of antibiotic resistance and/or tend to be more invasive (cause meningitis or bacteremia–blood infections).  The vaccines (Prevnar, Pneumovax) used against that bacterium focus only on the invasive or heavily drug resistant strains and have been extremely effective at minimizing invasive infections. 

    • #27
  28. DaveSchmidt Coolidge
    DaveSchmidt
    @DaveSchmidt

    Flicker (View Comment):

    DonG (CAGW is a hoax) (View Comment):

    As for Florida, it is a 40 minute boat ride to be in international waters. I expect some enterprising casino cruise business to add Covid Treatments. Blackjack, craps and Ivermectin here!

    Isn’t it against the law to travel out of the country for the purpose of committing a crime such as child prostitution or taking a covid therapeutic??

    Bill Clinton probably understands the law on this

     

    • #28
  29. OmegaPaladin Moderator
    OmegaPaladin
    @OmegaPaladin

    I’m curious where the clinical data on the antibody effectiveness is being presented.  It is disgraceful for the FDA to withdraw a treatment without at least linking to the studies or a review of studies

    • #29
  30. DrewInWisconsin, Oaf Member
    DrewInWisconsin, Oaf
    @DrewInWisconsin

    OmegaPaladin (View Comment):

    I’m curious where the clinical data on the antibody effectiveness is being presented. It is disgraceful for the FDA to withdraw a treatment without at least linking to the studies or a review of studies

    They’d only link to fraudulent studies that say what they want them to say, anyway.

    The FDA is thoroughly corrupt. And they’re killing people.

    • #30
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