FDA Resignations

 

There now appear to be a couple of casualties of the politicization of the FDA: Marion Gruber and Phil Krause, respectively the director and deputy director of the Office of Vaccines Research and Review. These gentlemen have resigned from the FDA, apparently over the political pressure for vaccine approval and use.

The particular issues appear to be Biden’s public announcement that he will be pushing boosters for everyone as of the third week in September, despite lack of FDA approval for such use (the FDA has approved the vaccine boosters for immunocompromised individuals only). Another issue appears to be the pressure on the FDA to approve vaccines for children. Also, it appears these officials objected to the CDC driving vaccine policies while infringing on FDA authority. No mention is made regarding the pressure for full FDA approval of the vaccines (superseding the EUA) which was announced about a week ago.

One wonders if that rush to full approval was part of the problem that led to these resignations. There are a number of straws that could have broken the camel’s back in regard to recent (as well as long-standing) FDA behavior, which has always factored in a large political component and pressures unconnected to the “science” that is supposed to underpin drug and vaccine approval.

These resignations are a blow to confidence in the FDA, the CDC, the Biden administration (confidence in which is plummeting due to the Afghan pull-out debacle), and in the use of the vaccines. These resignations won’t help encourage the vaccine-hesitant to get vaccinated, nor those already vaccinated to get the boosters.  To the contrary.  The resignations will tend to sow confusion and chaos in the Administration’s approach to COVID-19. Not surprising for this Administration.

I for one am impressed that there exist officials in the Federal Government with sufficient backbone to stand up and say enough is enough. It’s a tragedy that no one with such integrity exists in the Defense Department, the Joint Chiefs of Staff, or the State Department.

Published in Healthcare
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  1. Arahant Member
    Arahant
    @Arahant

    Nanocelt TheContrarian: I for one am impressed that there exist officials in the Federal Government with sufficient backbone to stand up and say enough is enough.

    Amen to that. I’m shocked, and not in the Casablanca way.

    • #1
  2. Old Bathos Moderator
    Old Bathos
    @OldBathos

    Not to undercut any element of principle involved, but a directive to bypass all normal procedures and protocols is also a major turf violation.  If you respect the agency where you served for years, you don’t go along with unlawful attempts to distort its role and mission for political expediency.

    There is no need to rush a vaccine for kids because (a) COVID-19 is not a significant novel level of risk (b) kids are lousy transmitters and so a vaccine might not have much effect on an already very small transmission risk, and (c) the risk of adverse reaction is likely to be higher than any benefit.  So as a matter of science and conscience, a kids’ vaccine cannot be rushed.  A vaccine for kids is pure political eyewash anyway.

    There is limited urgency in developing a new booster.  Existing vaccines for the elderly have cut COVID lethality by an enormous margin and there is no reason why existing or slightly modified vaccines cannot be used as a booster and all tested in a timely fashion.

     

     

    • #2
  3. Nanocelt TheContrarian Member
    Nanocelt TheContrarian
    @NanoceltTheContrarian

    Old Bathos (View Comment):

    Not to undercut any element of principle involved, but a directive to bypass all normal procedures and protocols is also a major turf violation. If you respect the agency where you served for years, you don’t go along with unlawful attempts to distort its role and mission for political expediency.

    There is no need to rush a vaccine for kids because (a) COVID-19 is not a significant novel level of risk (b) kids are lousy transmitters and so a vaccine might not have much effect on an already very small transmission risk, and (c) the risk of adverse reaction is likely to be higher than any benefit. So as a matter of science and conscience, a kids’ vaccine cannot be rushed. A vaccine for kids is pure political eyewash anyway.

    There is limited urgency in developing a new booster. Existing vaccines for the elderly have cut COVID lethality by an enormous margin and there is no reason why existing or slightly modified vaccines cannot be used as a booster and all tested in a timely fashion.

     

     

    Exactly. Plus other effective approaches are available for those at risk (Regeneron monoclonal ab cocktail, for example).

    • #3
  4. No Caesar Thatcher
    No Caesar
    @NoCaesar

    Setting aside the cause for the resignations, I am truly impressed that two senior members of the Swamp resigned over a point of principle.  Good on them.

    On the one hand, we have two officials standing up against the incomparable level of politicization of the Scientific and medical community by the Left.  On the other hand the FDA is notorious for over-regulation.

    Not sure where this lands, but, again, we should praise those who resign on Principle.

    Secretary Austin?  General Milley?  Secretary Blinken?  Are you paying attention?

    • #4
  5. MarciN Member
    MarciN
    @MarciN

    The disagreement must be profound for these two scientists to be making such a public statement. They are obviously worried about something. Let us hope in the weeks ahead they are not censored. 

    • #5
  6. Mark Alexander Coolidge
    Mark Alexander
    @MarkAlexander

    MarciN (View Comment):

    The disagreement must be profound for these two scientists to be making such a public statement. They are obviously worried about something. Let us hope in the weeks ahead they are not censored.

    Let’s hope the whole sterilization thing actually IS just a crank conspiracy theory.

    • #6
  7. Bryan G. Stephens Thatcher
    Bryan G. Stephens
    @BryanGStephens

    So let me get this straight:

    We have people willing to resign against a Biden Policy? I am having trouble buying into that. I mean, no one resigned from the apparatchik for Trump, and he was the greatest threat to the Republic ™ in history.

    • #7
  8. Saint Augustine Member
    Saint Augustine
    @SaintAugustine

    Old Bathos (View Comment):
    There is limited urgency in developing a new booster.  Existing vaccines for the elderly have cut COVID lethality by an enormous margin and there is no reason why existing or slightly modified vaccines cannot be used as a booster and all tested in a timely fashion.

    What do you think about using alternative vaccines for boosters? Take JJ as a booster if you’ve had Pfizer? Or Novavax a little later? Let Americans take Oxford? Maybe even approve Sputnik or Sinovac for booster purposes?

    Are these good ideas?

    • #8
  9. Saint Augustine Member
    Saint Augustine
    @SaintAugustine

    Old Bathos (View Comment):

    There is no need to rush a vaccine for kids because (a) COVID-19 is not a significant novel level of risk (b) kids are lousy transmitters and so a vaccine might not have much effect on an already very small transmission risk, and (c) the risk of adverse reaction is likely to be higher than any benefit.  So as a matter of science and conscience, a kids’ vaccine cannot be rushed.  A vaccine for kids is pure political eyewash anyway.

    There is limited urgency in developing a new booster.  Existing vaccines for the elderly have cut COVID lethality by an enormous margin and there is no reason why existing or slightly modified vaccines cannot be used as a booster and all tested in a timely fashion.

    Things that can be true at the same time.

    It’s still Warp Speed for the vaccines. But definitely not Warp Factor Ten.

    • #9
  10. Saint Augustine Member
    Saint Augustine
    @SaintAugustine

    Old Bathos (View Comment):
    There is no need to rush a vaccine for kids because (a) COVID-19 is not a significant novel level of risk (b) kids are lousy transmitters and so a vaccine might not have much effect on an already very small transmission risk, and (c) the risk of adverse reaction is likely to be higher than any benefit

    One more question for you, or for Nanocelt, or for anyone:

    Any guesses at what age this begins to be the case? 15? 18? 20? 25? 30? 35? (I’ve heard the same sort of idea applied as high as age 50! From a vaccine defender!)

    • #10
  11. Arahant Member
    Arahant
    @Arahant

    Saint Augustine (View Comment):

    Old Bathos (View Comment):
    There is limited urgency in developing a new booster. Existing vaccines for the elderly have cut COVID lethality by an enormous margin and there is no reason why existing or slightly modified vaccines cannot be used as a booster and all tested in a timely fashion.

    What do you think about using alternative vaccines for boosters? Take JJ as a booster if you’ve had Pfizer? Or Novavax a little later? Let Americans take Oxford? Maybe even approve Sputnik or Sinovac for booster purposes?

    Are these good ideas?

    I would want to be careful about that.

    • #11
  12. Saint Augustine Member
    Saint Augustine
    @SaintAugustine

    Arahant (View Comment):

    Saint Augustine (View Comment):

    Old Bathos (View Comment):
    There is limited urgency in developing a new booster. Existing vaccines for the elderly have cut COVID lethality by an enormous margin and there is no reason why existing or slightly modified vaccines cannot be used as a booster and all tested in a timely fashion.

    What do you think about using alternative vaccines for boosters? Take JJ as a booster if you’ve had Pfizer? Or Novavax a little later? Let Americans take Oxford? Maybe even approve Sputnik or Sinovac for booster purposes?

    Are these good ideas?

    I would want to be careful about that.

    Because it’s just more experimentation with new products?

    • #12
  13. Fritz Coolidge
    Fritz
    @Fritz

    Just to pick a nit: the FDA did not give the Pfizer vaccine full approval. They gave Pfizer approval for a parallel product, one that is not even available for use in the USA, but in bureaucratic argle-bargle, the FDA claimed the formulation was the same as that under the EUA, so the one under the EUA could continue to be used in place of the approved one.

    Got that?

    Meanwhile, the media that could not be bothered to actually read the FDA’s letter went on and crowed that Pfizer’s vac was now “fully approved.” It is not.

    • #13
  14. MiMac Thatcher
    MiMac
    @MiMac

    It isn’t likely that the “rush” to approve or develop the vaccines was a factor-more likely arguments over boosters and the CDC’s recent overstepping of their bounds(eviction moratorium etc) and trampling on the FDA’s turf. The booster argument is over whether boosters are needed given the vaccines appear to still protect against severe disease. The argument for boosters is:

    1)multiple studies showing decline in antibody levels after  approx 6 months. This leaves out cell mediated immunity (which is important) but the theory is that lower antibody levels allow vaxxed to catch COVID-albeit mild cases(the anamnestic response & cell mediate immunity protect against severe disease). Nobody is really sure what the required level of antibody is.

    2)the recent (ie last week) publication of a paper from Israel showing that boosters given after 5 MONTHs to those over age 60 cuts the risk of severe disease up to 10+ fold. https://www.gov.il/BlobFolder/reports/vaccine-efficacy-safety-follow-up-committee/he/files_publications_corona_booster-27082021.pdf

    3)the concern that the drop of immunity over time will eventually allow severe cases to occur if we wait long enough. Death is a trailing indicator.

    the argument against the booster is that the majority of transmission appears to be by the unvaxxed & we have not yet seen a significant increase in severe infections among the vaxxed as the Pfizer vax has maintained strong protection against death etc (UK Pfixer 86% effective vs delta).The best data is for Pfizer as it was the 1st vaccine. I also get the impression the Feds are worried that by admitting that boosters are needed they are giving the message the vaccine isn’t great-but as before the Feds worry about the public’s perception too much & often fail to just give out facts.

    • #14
  15. Saint Augustine Member
    Saint Augustine
    @SaintAugustine

    MiMac (View Comment):
    2)the recent (ie last week) publication of a paper from Israel showing that boosters given after 5 MONTHs to those over age 60 cuts the of severe risk disease up to 10+ fold. https://www.gov.il/BlobFolder/reports/vaccine-efficacy-safety-follow-up-committee/he/files_publications_corona_booster-27082021.pdf

    Very useful information. Thanks.

    That’s 3 total Pfizers, isn’t it?

    • #15
  16. MiMac Thatcher
    MiMac
    @MiMac

    Saint Augustine (View Comment):

    MiMac (View Comment):
    2)the recent (ie last week) publication of a paper from Israel showing that boosters given after 5 MONTHs to those over age 60 cuts the of severe risk disease up to 10+ fold. https://www.gov.il/BlobFolder/reports/vaccine-efficacy-safety-follow-up-committee/he/files_publications_corona_booster-27082021.pdf

    Very useful information. Thanks.

    That’s 3 total Pfizers, isn’t it?

    yes-other vaccines require 3 doses so this would not be unique.

    • #16
  17. MarciN Member
    MarciN
    @MarciN

    MiMac (View Comment):
    I also get the impression the Feds are worried that by admitting that boosters are needed they are giving the message the vaccine isn’t great

    that’s what I think too

    MiMac (View Comment):
    but as before the Feds worry about the public’s perception too much & often fail to just give out facts.

    Yup. 

    • #17
  18. CRD Member
    CRD
    @CRD

    Fritz (View Comment):

    Just to pick a nit: the FDA did not give the Pfizer vaccine full approval. They gave Pfizer approval for a parallel product, one that is not even available for use in the USA, but in bureaucratic argle-bargle, the FDA claimed the formulation was the same as that under the EUA, so the one under the EUA could continue to be used in place of the approved one.

    Got that?

    Meanwhile, the media that could not be bothered to actually read the FDA’s letter went on and crowed that Pfizer’s vac was now “fully approved.” It is not.

    I am sorry but I don’t understand! What does a “parallel product” mean? If it’s the same as the one under EUA, then why not change EUA designation to fully approved? If it’s not the same, then what does the approval of product B has to do with product A? 

    • #18
  19. Ontheleftcoast Member
    Ontheleftcoast
    @Ontheleftcoast

    CRD (View Comment):

    Fritz (View Comment):

    Just to pick a nit: the FDA did not give the Pfizer vaccine full approval. They gave Pfizer approval for a parallel product, one that is not even available for use in the USA, but in bureaucratic argle-bargle, the FDA claimed the formulation was the same as that under the EUA, so the one under the EUA could continue to be used in place of the approved one.

    Got that?

    Meanwhile, the media that could not be bothered to actually read the FDA’s letter went on and crowed that Pfizer’s vac was now “fully approved.” It is not.

    I am sorry but I don’t understand! What does a “parallel product” mean? If it’s the same as the one under EUA, then why not change EUA designation to fully approved? If it’s not the same, then what does the approval of product B has to do with product A?

    I may be wrong about this but I think the question is: Can stocks of a product produced under an EUA then be relabeled and sold as the “parallel” brand name drug once it’s actually licensed by the FDA, or do you have to produce new doses of the branded approved drug following approval? I think it’s the latter. 

    • #19
  20. Saint Augustine Member
    Saint Augustine
    @SaintAugustine

    Saint Augustine (View Comment):

    MiMac (View Comment):
    2)the recent (ie last week) publication of a paper from Israel showing that boosters given after 5 MONTHs to those over age 60 cuts the of severe risk disease up to 10+ fold. https://www.gov.il/BlobFolder/reports/vaccine-efficacy-safety-follow-up-committee/he/files_publications_corona_booster-27082021.pdf

    Very useful information. Thanks.

    That’s 3 total Pfizers, isn’t it?

    Oh, now that I’m on the compy with a keyboard, quick observations:

    This is darn good evidence that a booster shot is a good idea for many, many elderly people.  It provides little or no support that younger people need a third shot.

    But, of course, that’s what the PTB will tell us.  [Grumble, grumble.]

    • #20
  21. MiMac Thatcher
    MiMac
    @MiMac

    Saint Augustine (View Comment):

    Saint Augustine (View Comment):

    MiMac (View Comment):
    2)the recent (ie last week) publication of a paper from Israel showing that boosters given after 5 MONTHs to those over age 60 cuts the of severe risk disease up to 10+ fold. https://www.gov.il/BlobFolder/reports/vaccine-efficacy-safety-follow-up-committee/he/files_publications_corona_booster-27082021.pdf

    Very useful information. Thanks.

    That’s 3 total Pfizers, isn’t it?

    Oh, now that I’m on the compy with a keyboard, quick observations:

    This is darn good evidence that a booster shot is a good idea for many, many elderly people. It provides little or no support that younger people need a third shot.

    But, of course, that’s what the PTB will tell us. [Grumble, grumble.]

    Could end up that the young need a booster at longer intervals (like tetanus) but the older (& sicker) people need one sooner. It is possible that after several boosters your immunity will not wane quickly and you can space out the boosters. Additionally, it might well be that the 1st 2 doses should be spaced out more since b/c of time considerations they didn’t really try to find the optimal dosing sequence, they just wanted to quickly find one that worked. Worst case is we get an annual dose like the flu. Hopefully, we will develop (& clinically proven) effective anti-viral meds in the near future.

    • #21
  22. Saint Augustine Member
    Saint Augustine
    @SaintAugustine

    MiMac (View Comment):

    Could end up that the young need a booster at longer intervals (like tetanus) but the older (& sicker) people need one sooner. It is possible that after several boosters your immunity will not wane quickly and you can space out the boosters. Additionally, it might well be that the 1st 2 doses should be spaced out more since b/c of time considerations they didn’t really try to find the optimal dosing sequence, they just wanted to quickly find one that worked. Worst case is we get an annual dose like the flu. Hopefully, we will develop (& clinically proven) effective anti-viral meds in the near future.

    Yeah, and that all sounds fine.

    What bothers me is that I’ll probably start being hassled soon to take a booster shot when I almost certainly have little to no need for one.  38 or so, in pretty good health, had two Pfizer shots in April or so.  Needed 9 Tylenol for the second dose.  They’ll be hassling me to take a third dose of some vaccine, any vaccine.  Unless I can hop on a plane to some American zone, here in Hong Kong the hassling will mean I can choose between Pfizer with a likely need for Heaven knows how many Tylenol and Sinovac with Heaven knows how small a chance of Bell’s Palsy and not a whole lot of immunity benefit.

    One reason I keep wishing we had more options.  I’d love to have JJ here; I wish America could have Oxford; etc.; etc.

    • #22
  23. MiMac Thatcher
    MiMac
    @MiMac

    Saint Augustine (View Comment):

    MiMac (View Comment):

    Could end up that the young need a booster at longer intervals (like tetanus) but the older (& sicker) people need one sooner. It is possible that after several boosters your immunity will not wane quickly and you can space out the boosters. Additionally, it might well be that the 1st 2 doses should be spaced out more since b/c of time considerations they didn’t really try to find the optimal dosing sequence, they just wanted to quickly find one that worked. Worst case is we get an annual dose like the flu. Hopefully, we will develop (& clinically proven) effective anti-viral meds in the near future.

    Yeah, and that all sounds fine.

    What bothers me is that I’ll probably start being hassled soon to take a booster shot when I almost certainly have little to no need for one. 38 or so, in pretty good health, had two Pfizer shots in April or so. Needed 9 Tylenol for the second dose. They’ll be hassling me to take a third dose of some vaccine, any vaccine. Unless I can hop on a plane to some American zone, here in Hong Kong the hassling will mean I can choose between Pfizer with a likely need for Heaven knows how many Tylenol and Sinovac with Heaven knows how small a chance of Bell’s Palsy and not a whole lot of immunity benefit.

    One reason I keep wishing we had more options. I’d love to have JJ here; I wish America could have Oxford; etc.; etc.

     Since my work is considered high risk and there is nothing magical about 8 months (had 2nd dose early January) I would take the booster now-but they will not release them until 9/20 unless you are immunosuppressed. I could lie and say I am taking prednisone but I will behave. I felt lousy after the 2nd dose so I will time my booster for when I am not working-easier to do since I recently went part time. Sounds like your reaction was worse-hopefully the booster will not be as bad.

    • #23
  24. Saint Augustine Member
    Saint Augustine
    @SaintAugustine

    MiMac (View Comment):

     Since my work is considered high risk and there is nothing magical about 8 months (had 2nd dose early January) I would take the booster now-but they will not release them until 9/20 unless you are immunosuppressed. I could lie and say I am taking prednisone but I will behave. I felt lousy after the 2nd dose so I will time my booster for when I am not working-easier to do since I recently went part time. Sounds like your reaction was worse-hopefully the booster will not be as bad.

    What I’d really like to avoid is needing more than 9 Tylenol.

    In theory, if the second shot did me any good, then my immune system was better equipped for the little spikes, and a third dose right off would have needed more than 9.

    But if I wouldn’t have needed more than 9, then what was the point of the second dose?

    Similarly, either I’d need a lot of Tylenol for a third shot or not.  If I do, it’s because I didn’t need a third dose.

    If I don’t, it’s because the second dose faded faster than I’d like.  But the longer I get to wait, the less of a problem this becomes.

    Still, I want options.  I’d sooner take some other vaccine to train my immune system to do something a bit different to fight the stupid virus.

    Anyway, I’ll stop rambling.

    (Prednisone is the best. It’s like Daflon for hemm. problems; it’s like a miracle cure for sinus problems.)

    • #24
  25. Old Bathos Moderator
    Old Bathos
    @OldBathos

    I had no reaction to the Moderna shots. I rarely get anything like a cold or flu.  I am old but absurdly healthy for one who is not exactly a fitness or dietary zealot.

    If my GP recommends a shot, I do it. I trust her judgment. If she suggests a booster, I will do it. 

    The current leadership of the federal health establishment is a freak show, incompetent and obsessed with managing public perception more than protecting public health.

    Best policy is to lay out the facts, admit uncertainties, make solid recommendations and let people decide what to do with it instead of making the politics of mandates the overriding concern.

     

    • #25
  26. Saint Augustine Member
    Saint Augustine
    @SaintAugustine

    Old Bathos (View Comment):

    Best policy is to lay out the facts, admit uncertainties, make solid recommendations and let people decide what to do with it instead of making the politics of mandates the overriding concern.

    Preach, Brother.

    • #26
  27. MarciN Member
    MarciN
    @MarciN

    Old Bathos (View Comment):
    I am old but absurdly healthy for one who is not exactly a fitness or dietary zealot.

    That is so interesting. I read a study years ago on longevity in which the researchers reported that the most accurate predictor of good health in a person’s fifties through eighties was the number of close relationships that person had. It was more accurate than all of the other “health” variables they looked at. 

    I know you have quite a few grandchildren. I’ll bet that’s why you are in good health. :-) 

    • #27
  28. Stina Member
    Stina
    @CM

    The vaccines did not require 3 doses until recently. All were 1 to 2 doses. It is not true that Pfizer adding a third shot brings it in line with other vaccines.

    Pfizer is now developing a twice daily pill to take alongside vaccines and quarterly boosters (seriously, no one is skeptical of that?). It is a protease inhibitor. If you can find the nih paper buried by the CDC, you will also discover Ivermectin is a protease inhibitor.

    That same nih paper refers to hydroxychoroquine as an anti-corona drug.

    Israel has the highest vaccination rates. They also have one of the highest infection rates.

    If I’m supposed to believe in evolution, then the MDs around here need to start believing in it, too. Evolution requires pressure on survival without outright killing. Even Israel has demonstrated that natural immunity is better than the vaccines. What is more likely to spin off variants? The unvaccinated that doesn’t have any resistance to the virus? Or the vaccinated that only have immunity built up against one, single protein?

    We are being lied to. And anyone with an MD after their name who wants to refute what I’ve just said is going to need to overcome a yawning chasm of distrust. “Trust me, I’m a doctor” isn’t going to cut it. My husband has that shirt, too.

    • #28
  29. Saint Augustine Member
    Saint Augustine
    @SaintAugustine

    Stina, you can trust me. I’m a doctor. Of philosophy.

    • #29
  30. Old Bathos Moderator
    Old Bathos
    @OldBathos

    MarciN (View Comment):
    I know you have quite a few grandchildren. I’ll bet that’s why you are in good health. :-)

    My grandfather and his older sister used to enjoy sitting on the sidelines pushing the buttons of their six siblings at (understandably) rare family gatherings. He theorized that nicer people die first and that he and (all but the nicest youngest sibling) all made it to a very old age out of sheer orneriness. Great Uncle Gene was kicked of the Canadian army (and maybe Canada) for punching an officer. Great Uncle Frank insisted on keeping his guns in their holster on his bedpost in a retirement home. (The nuns caved on the keeping-guns in the facility issue but took away the ammo.) They dutifully wrote down each word in his dictated letters (he was was illiterate to the end) including his colorful language insulting the nuns. Those two lasted into their late eighties when average lifespans were more than two decades lower.

    Other than the absence of obvious self-injurious habits, good health appears to be a gift or accident. Attitude, particularly influenced by social and personal connections does seem to matter. Maybe that’s why people whose whole purpose and whose human interactions were entirely occupation-related often find retirement lethal.

    • #30