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Trouble at the FDA and CDC

That title is the only way that I can describe the events of the last few days. Like so many other things this year, what we’re seeing now at the top of the drug regulatory structure is unprecedented, and not in a good way at all. Let’s recap.

A few days ago, HHS Secretary Alex Azar sent out what has to be considered a very unusual memo. Its key point (as written) is:

The authority to sign and issue any rule for which notice and comment would normally be required, irrespective of whether notice and comment is waived, is reserved for the Secretary. Any prior delegation of rulemaking authority, including the authority to sign or issue a rule or a proposed rule, is rescinded

Now, there’s a lot of disagreement about just what that means. The New York Times, in that link above, says that this change has been talked about for some time and is an assertion of HHS power over FDA decisions – and furthermore says that former FDA head Scott Gottlieb was fighting against such a change during his tenure. HHS has gone so far as to issue a statement trying to clarify this, saying that “The memo should have no effect on operational work and does not pertain in any way to guidances or any vaccine or drug approval or authorization. This action will not slow any HHS agencies’ work. It is simply the ministerial, administrative act of attaching a signature to a document“. The statement goes on to say that this will forestall challenges to regulations on the basis that the people issuing them did not have the proper authority to do so.

How often has that happened, exactly? And doesn’t that mean that any FDA approvals or rule changes will have no force unless the Secretary sees fit to attach that signature? Giving that Secretary that power to overrule them as he or she sees fit? And even if that’s not the memo’s intention – and I’m not convinced that it isn’t – wouldn’t this seem to be a very funny time to be promulgating such a rule, what with so many people worrying about what has been obvious political interference in the work of the FDA and CDC? And yes, I know that there will be people who will say that they haven’t seen evidence of such interference, but I’m not having it – look at the position the CDC has been put in, more than once, of having to say what the White House wants rather than what their own staff recommend.

And then there’s the case of Michael Caputo. He’s a political ally of the President who was put in as chief spokesman for HHS and is now taking medical leave after a bizarre Facebook rant where he accused the CDC of committing “sedition” against the president, that “the deep state scientists want America sick through November” and had earlier made comments about “ulterior deep state motives in the bowels of CDC”. I was actually not going to comment on this weird situation, figuring that Caputo himself had had some sort of breakdown, had apologized, and deserved a respite, but now I see that he’s publicly standing by his remarks and resents the idea that he has any sort of mental problems. So we should let him own this crap.

But why stop there when talking about political interference? The Times has also reported that the FDA is planning stricter guidelines for coronavirus vaccine approval, including clearer cutoffs for efficacy, separate advisory committee meetings for each vaccine, etc. But yesterday, the president let it be known that he doesn’t necessarily want anything of the kind:

That has to be approved by the White House,” he said, adding, “We may or may not approve it.” Raising questions about why vaccine makers would want to delay the process, he said, “We are looking at that, but I think that was a political move more than anything else.”

“We are looking at that” is one of Trump’s tropes, along with “many people are saying” and how everything is coming in two weeks, etc. But the suggestion that the FDA (and the drug companies themselves?) are deliberately dragging their feet on a vaccine is (A) wrong, (B) extremely harmful to public perception of the whole effort and to its eventual success, and (C) an insult that it itself beneath contempt. Oh yeah, and it’s (D) a direct slap in the face to Trump’s own FDA Commissioner, Stephen Hahn.

Earlier in the day, Hahn (and the heads of other agencies) had been in front of Congress, saying that they would not allow political pressure to take over from a scientific evaluation of the vaccine work. And Trump’s statement is what he gets for his trouble. The honorable thing to do would be to resign, honestly, but working for Donald Trump often seems to put people in a position where they feel that doing the honorable thing is an option that’s been closed off. Will Hahn stick up for his agency now? Or can he, since Sec. Azar has said that he has to sign off on anything of any importance? What a mess. What an absolute mess, and it didn’t have to be this way. None of it had to be this way.

160 comments on “Trouble at the FDA and CDC”

  1. Simon Auclair the Great and Terrible says:

    As we transition into an authoritarian one party state, all our institutions will be subject to increasingly naked political control.

    1. Maria R says:

      I wouldn’t call Nancy Pelosi or Joe Biden “authoritarian”. Do you have evidence?

      1. Scott says:

        Yeah, Pelosi’s a real everyman with her $20/pint ice cream and behaving like she’s exempt from the rules that apply to everyone else.

        Biden’s fine, you just have to be worried about who’s pulling his strings.

        1. J N says:

          You may have “aristocratic” and “authoritarian” confused.

          More like “blue blood” actually.

        2. UserFriendly says:

          You people need to get over yourselves. This country has done nothing but corruption for the last 40 years. Trump just has no shame and says the quiet parts out loud. If this country wasn’t corrupt to the core most of the Bush admin would be in jail for war crimes in Iraq. So would Wall Street for the unimaginable amount of fraud in 2008. And the Obama admin for turning Libya into an open air slave market and helping the Saudi’s commit genocide in Yemen. But those were all MASSIVE failures by elites, and in this useless country elites get promoted when their greed and incompetence kill millions. But one of us peons so muchs a smokes a joint and we go to jail for years.

          The only question that is on the ballot is ‘Would you like the news to treat all the corruption as insane brazen and norm shattering? or would you like them to pretend it isn’t happening?’ Materially improving your quality of life, is as usual, not ever on offer.

          1. DrivingWithDaisy says:

            I try not to wade into a political points on this blog, I will step in it far enough to say that I think you have a stated a refreshing counterpoint.

            There is much to be said on the topic, unfortunately the little meeting is covered by much noise.

    2. UserFriendly says:

      We’ve been an authoritarian one party state for 40 years.

      1. Chris Phoenix says:

        The Democrats wrote the first version of the PATRIOT Act, and the Republicans opposed it on civil liberties grounds. Then the Republicans came into power, and 9/11 let them push it through.

        1. Barbara Piper says:

          I think you will find that the early history of the Patriot Act is much more complex than you describe. The Act was the product of several initiatives, but the bill that became what we know as the Patriot Act was written by Orin Hatch, Republican of Utah, Trent Lott, R of Mississippi and Paul Sarbanes D of Maryland. It was introduced to the Senate by Tom Daschle, a Democrat, but I cannot imagine any sense in which it was written by Democrats. The Senate passed the original Patriot Act with only a single vote in opposition; the House had passed the bill the day before 357 to 66.

          1. UserFriendly says:

            It was written by the intelligence agencies. It was voted on by a bunch of corrupt politicians who are almost certainly being blackmailed by the intel agencies. The problem with having totally uncountable centers of power who don’t need a warrant to look at anyones personal data is that there is no way to kill it off once it starts. It is unfathomable that they don’t have dirt on almost everyone with money or power.

    3. Pathcoin1 says:

      Well said. This observation is stated from many angles: It is the nature of government to expand its power at the expense of the liberty of the individual. Organizations act as supra-organism that seek their own survival. Power corrupts and absolute power corrupts absolutely.

  2. Matthew says:

    Thankfully those agencies are made up of dedicated, highly professional civil servants.
    The gibberish at the top doesn’t significantly affect the work these people do every day.

    1. Churlish says:

      Matthew, I both strongly agree and disagree. While I maintain my faith (!) in the motivations of the professionals at the FDA and CDC, it’s not clear that their opinion matters at present.

      The actually decisions are being made in the name of the agencies at the level of the politicians and their appointees, without reference to the work of the professionals. The decisions in the names of the FDA and CDC are what impact us.

  3. Sam Weller says:

    I agreed with everything up until the last two sentences. It actually had to be this way – that is the populism that Trump has been elected to deliver.

  4. Steven says:

    The politicization is a problem, but I also have the impression that the FDA is not treating the pandemic as the emergency that it is. Where are the challenge trials? Why introduce stringent criteria for emergency authorizations? It would not be hard to tailor the EUA so that they are released to groups whose risk from Covid is greater than their risk of side effects from the vaccine.

    I do not, in principle, have a problem with elected officials overseeing a government agency. Even if I have doubts about Trump’s ability to do so, the situation is inherently political and the case is overstated.

    1. Stu West says:

      Challenge trials have been addressed here before and the rationale for them is pretty dubious. Just looking at yesterday’s announcement that the UK is pressing ahead with them, there’s so much additional complexity that they’re not going to be able to get started until January. Also, the UK regulators note that challenge trials are most useful when the virus isn’t circulating widely in the population, and also that they require a rescue remedy to prevent serious illness, neither of which describe where we are with Covid. (The “rescue remedy” they’re using is remdesivir, which, if it worked the way they are claiming, we wouldn’t need a vaccine in the first place.)

      1. Willy says:

        “Challenge trials have been addressed here before and the rationale for them is pretty dubious. Just looking at yesterday’s announcement that the UK is pressing ahead with them, there’s so much additional complexity that they’re not going to be able to get started until January. Also, the UK regulators note that challenge trials are most useful when the virus isn’t circulating widely in the population, and also that they require a rescue remedy to prevent serious illness, neither of which describe where we are with Covid. (The “rescue remedy” they’re using is remdesivir, which, if it worked the way they are claiming, we wouldn’t need a vaccine in the first place.)”

        Most of the problems are regulatory and ethical choices, not intrinsic features of challenge trials. Many people signed up through 1daysooner with no rescue therapy.

        1. Mariner says:

          I have to say, I’d be absolutely astounded if China and perhaps Russia haven’t already been carrying out challenge trials of their vaccines on ‘volunteers’ in various prisons/internment camps. For that matter, it wouldn’t be a surprise if the same was occurring in certain Western countries or elsewhere at the behest of Western countries as well. Not as though the various TLA organisations are known for their moral turpitude when it comes to the area of human rights.

          1. eyesoars says:

            Perhaps you meant ‘rectitude’ rather than ‘turpitude’?

          2. Mariner says:

            Correct, of course. I did intend to say rectitude. Got my morals all mixed up. 😉

        2. matt says:

          “Most of the problems are regulatory and ethical choices, not intrinsic features of challenge trials. ”

          There are intrinsic features that are problematic. How are you going to “challenge” your patients? Inject them with virus? How representative is that of an infection in the real world? No one is injected with virus in the real world, it typically comes through respiratory contact for this virus. How much viral material do you inject, and how did you choose that amount? Or are you going to snort it? If your vaccine fails to prevent an infection, but makes it milder, how do you know you didn’t “challenge” with vastly more viral material than would be seen in the real world, and you are being over-conservative? (That is, efficacy looks much worse than it would in a non-challenge trial.) Or is it less and you are being under-conservative? (That is, efficacy looks much better than would be seen in a non-challenge trial.) If you can’t distinguish those two propositions, how much are you learning, exactly?

          You will actually need some data on your challenge protocol, in other words, infecting people just to sort out those numbers.

          If you pick a younger cohort, so that you aren’t likely to have deaths on your conscience, how does that apply to the people who really need the protection of the vaccine?

          And besides all that, the ethically challenged or ignorant “challenge trialers” just don’t get it. Just because someone volunteers for something does not make it all okey-dokey to administer that something to them. Here’s a little thought experiment: if a friend is all about “really living life and not being ruled by fear” and not just volunteers but begs you to hold the revolver and spin the cylinder and pull the trigger on them for Russian roulette, is it ethical? Will you escape being prosecuted under the law for that act if they die? (No.) Why, if you have a signed consent form?

          Stop agitating for the world to be less ethical.

          1. ghyu says:

            Strange times when allowing an adult to put himself in danger in order to save thousands of lives is regarded as unethical. What about the soldier who risks his life for the commercial or political benefit of his country? I think challenge trials are a worthier cause than most wars and the death rate is likely much smaller!

            The technical challenges are smaller than you make them out to be. If a challenge trial can be done in monkeys with no major difficulty, you can do the same in humans. Of course you wouldn’t inject the virus into the blood, you’d make them breathe it in. You could even avoid the artificial infections by creating superspreading conditions or asking people to sing in a choir with infectious people. At this point in the pandemic we even have so many different strains of the virus that we should be able to pick one that’s slightly less deadly.

          2. Robert says:

            I think the conclusion is that the challenge trials can’t give useful data (or can’t give useful data that can’t be gotten without doing intentional harm to subjects) and so any hurt done by them is unacceptable. People willing to help others isn’t the moral problem here.

      2. Hopeful Layman says:

        Okay, this is probably another “Layman’s” question — but what about a “natural challenge trial”? Pick a medium-sized city — 60,000 – 100,000 population, let’s say — and divide it in half between randomly selected cases (who get the vaccine) and controls (who get the placebo). In theory, you have equal diversity — age, ethnicity, incoome, pre-existing conditions, etc. — in both groups. Not being a statistician I don’t know how many cases of COVID would have to appear in each group for the test to be statistically significant, but all else being equal, we can probably assume a roughly equivalent infection rate. Why couldn’t the vaccine be tested this way? We’d also eliminate the problem, which has mentioned here, of self-selection — people who volunteer for a test like this are ikely to be more aware of the issue, more careful in their behavior, and thus less likely to get infected, meaning that volunteer trials will probably take longer and may not represent the way most “normal” people would get infected and then respond to having the virus.

        Is there a reason it can’t be done this way? I’m guessing that getting permission from the test subjects might be the most insurmountable barrier, but I’d love to know if something like this has ever been tried, and if so, how well it’s worked.

        1. eub says:

          That’s just a normal vaccine trial except instead of using volunteers, you’re… what? Guilt-tripping people? Offering levels of cash money that will buy the cooperation of even the most reluctant?

          How does this work outside Xinjiang?

          1. ghyu says:

            Built an artificial village, fill it with volunteers and invite some asymptomatic infectious people, then party like it’s 2019. Shouldn’t take long to get the placebo group infected.

    2. PDINV says:

      Given how remdesivir got and still maintains its EUA status, I wouldn’t say that criteria for EUA are exactly strict. If they wanted to try combinations, they could have just kept doing combination trials as they have been doing before EUA and still doing now, until they find something that remotely works with remdesivir (good luck with that).

  5. Simon Auclair the Great and Terrible says:

    Biden isn’t running things.

  6. One sad sack says:

    It truly has dumbfounded me that we are being led toward becoming an authoritarian state, accidentally, by a moron that does not know what he is doing to make himself an autocrat. I never thought that I would see the United States devolve into this, by accident.

    1. Fraud Guy says:

      It’s been a deliberate move since Nixon and his Southern Strategy: how to govern with an ever smaller coalition.

  7. John Thacker says:

    There is a valid and entirely reasonable legitimate dispute about the proper way to balance risk for approving both treatments for the ill as well as preventative medicine like vaccines. It’s not purely a question of expected deaths or scientific judgement either; since the public generally views harms from side effects as worse than an equal number of deaths or morbidity from diseases that could have been mitigated with unapproved or not yet approved treatments, the FDA and CDC are restrained by public opinion (and their view of such) in a way that extremely likely results in more overall deaths than optimal action. That applies in both cases where the FDA overregulates as well as in cases of inaction – public opinion may very well make mandatory full isolation centralized quarantine impossible in the US regardless of how many theoretical lives it would have saved in my opinion. But the public, in the view of experts, will not accept hundreds of Guillain-Barre cases in order to save thousands or tens of thousands of deaths, at least that is the lesson of 1976 (and in a way, the legacy of Andrew Wakefield.)

    A corollary of that is that since Trump is an incredible liar, his very presence alters how one deals with that judgement call. Aside from all the times he inflames public opinion of his supporters away from correction action, even if and when in a particular case he hits upon a correct argument (surely for the wrong reason) he makes it less tenable by driving public opinion of another segment away. The FDA, as a public health agency, tempers their actions based on what they think the public will accept, not just what will save lives. (In many cases they have internalized this view, and do not always admit even to themselves that it’s not a judgement of pure science or ethics.) That is appropriate, but it is also appropriate to overrule that decision in some cases (the FDA extreme reluctance to approve tests early on and rapid even if somewhat less accurate tests now are to me good examples.)

    However, Trump is literally incapable of making that case.

  8. Anon says:

    Having the need for HHS to sign off on an EUA would be a way for the government to select Moderna over other vaccine candidates (Pfizer?) should they cross the finish line together and look equivalent. The USA threw a lot of money at Moderna and winning “good deals” is always a considerable sore point with Trump.

  9. M says:

    Congress needs to start doing a better job of reigning in the executive branch. Executive Privilege has been expanding for decades, and now the current administration has stretched it well beyond anything resembling normalcy. Trump will be gone eventually, but the damage done and doors opened for future presidents won’t easily be undone and closed.

    1. Derek Lowe says:

      I agree – the legislative branch has (for many years now, and over many administrations) been abrogating its power because of the desire to be re-elected more easily. And one of my worries about the Trump years is that the precedents that have been broken will stay broken, because there are partisans of all sides who will be only too glad to help themselves to any new powers when the Right Sort of People are in charge. You have to object to power grabs on principle, and not just because your people aren’t getting the benefits of it.

      1. Is this new? says:

        “And one of my worries about the Trump years is that the precedents that have been broken will stay broken, because there are partisans of all sides who will be only too glad to help themselves to any new powers when the Right Sort of People are in charge.”

        Hasn’t this been true for many administrations? Obama intervened militarily in Libya without consulting Congress, and decided that he didn’t like our immigration laws and created a new class of illegal immigrant by executive fiat.

        I actually don’t see anything policy-wise that Trump has done that has breached what previous administrations have done. Rhetorically, yes, Trump has violated many norms of the Presidency. But in terms of actually expanding Executive power I don’t really see anything in excess of what Obama and Bush II did.

        1. M says:

          In terms of raw numbers, Trump has issued more executive orders per year of his presidency than anyone since Carter. But not by a whole lot. You can see the table here:

          https://en.wikipedia.org/wiki/List_of_United_States_federal_executive_orders

          Few people can hold a candle to FDR (who really started the large scale expansion of EP), and Trump isn’t decisively ahead of Reagan, but he outpaces both Bushes, Clinton and Obama by a decent amount.

          1. confused says:

            FDR, in my opinion, gets too much credit for short-term success with the Great Depression, and too little blame for how his actions set precedents that fundamentally changed how the federal government works.

            Trading long-term stability of the system to deal with an immediate crisis is rarely a good idea.

          2. Marko says:

            “FDR, in my opinion, gets too much credit for short-term success with the Great Depression, and too little blame for how his actions set precedents that fundamentally changed how the federal government works….Trading long-term stability of the system to deal with an immediate crisis is rarely a good idea.”

            You are indeed confused , confused. FDR was re-elected THREE times , and it wasn’t because of the support of the elites , it was because of working-class support. There’s a good reason that his death resulted in a level of grief across this country that has rarely been seen , before or since.

            The fundamental changes he made ushered in the three following decades that came to be known as the Golden Age of Capitalism , not just in the US , but across much of the Western world. American institutions , like for instance the FDA and CDC , achieved and maintained their “Gold Standard” reputations during this period , reputations that have since been tarnished , and not just under Trump. Similarly for international organizations , like the UN , which , believe it or not , was then held in quite high regard. No more , of course.

            The deconstruction of the FDR framework started in the ’70s , ramped to Warp Speed in the ’80s , and has continued apace since. The end result is this shithole of a failed state with nukes that we’ll be living with for a long time , no matter who is elected on Nov 3.

          3. confused says:

            Oh FDR was reelected because he *did* help tons of people. His policies were genuinely effective, then.

            But the precedents he set (both his own actions and some decisions of ‘his’ Supreme Court) badly unbalanced the “balance of power” between the different parts of the government. The ‘cost’ paid for his achievements didn’t start coming due until long after his death, when other people were in power.

          4. confused says:

            And I would argue the success of the following decades was largely due to technologies resulting from WW2 & industrial growth, plus the further advancement of trends already begun (mechanization of farming -> fewer people needed in farming jobs so more people available for industrial jobs, etc.). And by the time you get to the 60s opportunity for more people as well.

            I’m also not nearly as pessimistic about the long-term future of the US. IMO this is very likely to be an election about ‘stability’ – as a sharp contrast to 2016, which was largely about rejecting the existing political order – and things will re-stabilize rapidly after January.

            Now, ‘re-stabilize’ doesn’t mean ‘return to exactly how things were before’, but I think we will actually end up with stronger institutions & ones better adapted to 21st century realities after this stress to the system.

        2. Dark Day says:

          ” . . . in terms of actually expanding Executive power I don’t really see anything in excess of what Obama and Bush II did.”

          Is there precedent for what he’s threatening to do, in terms of overriding the FDA on a vaccine? And certainly, if he makes good on his implied threat to attempt to stonewall the results of this year’s election, that will be an unprecedented step. Even Nixon didn’t try that with Kennedy in 1960, and, to be honest, those results actually were a little shady (e.g., Richard Daley, Illinois, etc.).

        3. eub says:

          I agree that Obama’s (and Bush’s) use of executive power was problematic — DACA, for one, is policy I strongly support, but institutionalized non-enforcement of statute cuts all ways — but Trump’s executive branch is qualitatively different. He has moved beyond specific attributable executive pronouncements to an inculcation of personal loyalty within the law enforcement apparatus. Bill Barr is personally pulling strings to get desired outcomes for the President’s buddies who broke laws. He and Durham are quite openly aiming for an October Surprise. Now the DOJ is making press releases which it coordinates with the White House to cast suspicion on election results (linked from name).

          Executive actions are a problem. Co-opting the executive apparatus for personal goals is different.

      2. Dr. Faustus says:

        So it’s come to this. Derek has posted a purely political comment. Fraught times indeed…

        1. MagickChicken says:

          “Political interference at the FDA & CDC” is not about Derek’s politics, it’s about the bureaucracy. It doesn’t matter which political party is doing it, what matters is that the science is being given a backseat to *other people’s* political machinations. It could be Biden, HRC, Pence, or Romney, it wouldn’t matter, because it’s bad.

          1. Dr. Faustus says:

            I meant to point to a comment by Derek that was purely political, with no relevance to drug discovery or chemistry. He was drawn into a dialog that is of arguable essence in our lives, but not what Derek should need to engage. He’s got a day job.

          2. J N says:

            There has been some pretty heavy-handed public health-related political arm twisting as long as public health has existed. Normally, one foot in science and the other foot in politics, from both parties.

            HIV/AIDS for example, abortion, CO2 being declared a pollutant, CA carcinogen notices, cellphone radiation standards, gun violence as a public health matter, etc.

            So, this kind of manipulation isn’t fundamentally new.

            What is fundamentally new, though, is that there isn’t a foot in science. There isn’t even a toe there. It’s just manipulation of communication.

            I do remember, what was it, attempts to control messaging around climate change in the Bush administration, but they weren’t particularly effective or durable, and certainly W and the administrator of the EPA weren’t calling out individual scientists on live TV.

            So, there is a change here, a Nixon- J Edgar Hoover sort of change, except with “the quiet part out loud.”

        2. Philip says:

          Facts are not political. That a political party ignores facts is a news story, but not a political one.

      3. M says:

        Derek – well said.

        The expansion of Executive Privilege and how we handle our Supreme Court nominations are two very important issues. One gets a lot of attention, the other deserves more attention.

      4. Churlish says:

        For example, the United States hasn’t formally declared war on anyone since it joined the Second World War. All military actions after that (Korea, Vietnam, Grenada, the Iraq wars, the ‘War on Terror’, etc & etc) were authorized and run by the Executive with Congress staring at their shoes.

        1. Dark Day says:

          . . . with the exception of Desert Storm, right?

          1. Marko says:

            I think the main change has been that we no longer declare war , we authorize the use of military force. It just sounds “nicer”.

            The Gulf War , the Tonkin Resolution , and the current and forever-lasting AUMF are all examples of repackaged war declarations , all predicated on lies , BTW. Remember incubator babies ?

        2. matt says:

          There was an authorization for use of military force both in 1991 and 2001, and the 2001 AUMF essentially has been continued as needed as an endless “war on terror.” I recall a vote in Congress on the Iraq war. And I recall that politicians who voted for, primarily on the Democratic side after Democrats decided it was a bad idea, had those votes used against them.

  10. Dark Day says:

    When / if the Trump administration is out of the picture, do people think that new, more accurate and coherent messaging might bring enough Americans around to trusting vaccines again, to allow at least the possibility for adequate uptake of whichever COVID Vaccine[s] can successfully complete Phase III? My own personal opinion is that perhaps a vaccine that completed the process a little later — maybe J&J, maybe Novavax or Merck, maybe Sanofi — might do better in ths regard. But what would this mean for a vaccine that had actually been pushed through for approval when Trum was still in charge? Would Pfizer or Moderna end up stuck with millions of “white elephants” in vials that no one wanted to use?

    1. anon says:

      Sanofi and Novavax are making essentially the same thing using the baculovirus production system and formulating with a potent adjuvant. Sanofi could win that long-term because of experience. Also they have an accepted adjuvant licensed from GSK. Novavax using unlicensed adjuvant that might be too “hot” compared to Sanofi and show more AEs.

      Could be the best high-volume vaccine ultimately for licensing, cost and world distribution.

    2. anon says:

      Merck vaccine (VSV) might be effective at one dose, like for Ebola, but will have the later boosting problem as with Ad vectors confronting pre-existing immunity to the vector.

    3. Dark Day says:

      Anon, I agree — speaking just for myself, I’m perfectly willing to wait another few months to see how J&J, Novavax, and Sanofi fare in their Phase III trials. My question, though, had more to do with restoring public trust — that, I believe, will be the most challenging hurdle. (After all, most “normal” people don’t read this website!!)

      1. J N says:

        Right, I honestly don’t know who Trump is talking to:

        * His “freedom loving” anti-vaxxer base, or
        * The other side, who are going to take a politically approved vaccine regardless of its actual unproven efficacy, never.

        1. DruvingWithDaisy says:

          I’m not sure he’s talking to anyone in particular. It seems to me a flippant, thoughtless comment which hopefully will join the other such comments Trump is made in being completely relevant to what he or the administration does.

          Not a few of the administration’s actions in other realms have actually been well considered and effective. It’s as if there are two different Donald Trumps living in the same body

          1. BreakdownLane says:

            “. in being completely irrelevant, that was meant to be

          2. Dark Day says:

            Actually, I have to give credit where it’s due — Although, like Fauci and many others I never liked the name, “Operation Warp Speed” is really a pretty remarkable, if not historic, public-private partnership, and the administration was amazingly efficient in getting it off the ground. If Trump had just stood back and let the scientists do their thing with the support and assistance provided, he might have gone down in history as a great man after all. And that’s coming from a diehard Trump-hater.

    4. Eric Jacobsen says:

      Inovio INO-4800 DNA plasmid vaccine. Stable at at room temperature for over a year thus no cold storage issue anywhere in world. A consortium of manufacturers and anticipating 100M dose production in 2021. Commitment to safety (only grade one adverse events in phase 1) and efficacy (T-cell immune response and memory immune response at 17 weeks after immunization in non-human primates). Inovio has been under the political radar but anticipating iniating their phase 3 trial in September.

      1. matt says:

        Still got your money on Inovio, eh?
        I’m not sure if you realize how foolish it is to say only one mild adverse event in phase 1, but it is. The equivalent is a review of a car that says, “I just bought it today, but it’s been very reliable so far.”

  11. c says:

    Is anyone else getting increasingly concerned that the political situation in the US isn’t being taken seriously enough?

    Trump and his allies don’t even bother pretending to be interested in unity anymore. There is total warfare happening on the (most impressionable) minds of the American public and the best we can do is decry a few Twitter rants?

    Is there still an expectation we’ll return to normalcy when (if) Trump is gone? This is just the beginning of the madness. The falcon cannot hear the falconer.

    1. confused says:

      What is “normalcy”?

      IMO the current situation is quite analogous to the late 60s/Nixon era (or going back farther, the Great Depression/FDR era or Andrew Jackson in the early 19th century).

      The US political parties tend to go through a rather chaotic shift about twice per century.

      I think *stability* will return sooner than expected, but that stable state will look different from the pre-2016 one, comparable to the difference between 1965 and 1975 maybe.

      So I think change will absolutely happen, but I doubt chaos will continue to increase. There is a lot of institutional inertia working against that. The actual operations of the federal government don’t seem to me to have been changed nearly as much as rhetoric suggests (*either side’s* rhetoric).

      Honestly even the 60s analogy might be an overstatement. I do think we are headed to a realignment/political shift, but it might be a smaller one, more like the early 20th century one with muckrakers & Teddy Roosevelt.

      This looks dramatic largely because most of us weren’t around, or at least weren’t old enough to be really aware of politics, the last time this happened.

      1. c says:

        We have a sitting president calling an election into question before it’s happened. He is intentionally sowing doubt in the process in a totally unprecedented way.

        A great deal of this relies on reasonable sounding people saying “actually this isn’t so weird, remember how much of a crook Nixon was?”

        What’s the limit? How far does discourse descend while the mostly unaffected, financially secure, politically insulated people say “actually there isn’t much to worry about if you think about it”?

      2. Dark Day says:

        I was around in 1968, which was a year that at the time felt as apocalytpic (assassinations, student riots, urban “long hot summers,” as 2020 feels for many people (albeit without a pandemic to further complicate things). And yes, things eventually got back to “normal” (if the 1970s can be considered “normal!”), even though Nixon put the country (and the world, especially Southeast Asia) through some pretty dire change over the next eight years.

        The one new factor we need to consider today, though, is social media. It’s almost a shadow government in and of itself, and I don’t think its powers and potential (for both good and ill) have yet been fully grasped. Both knowledge and ignorance can be transmitted worldwide in less than a second — and, since our world seems to be full of a lot more of the latter than the former, it’s enough to temper the optimism of even the most determined Polyanna.

        1. confused says:

          Actually, there *was* a pandemic (flu pandemic of 1968-1969).

          The parallels are really very striking.

          Including, on the positive side, the revitalization of the US human spaceflight program this year (with SpaceX’s Dragon 2)…

      1. Marko says:

        As if 2020 hasn’t been bad enough already , we now know that the worst is yet to come.

        Is there any info out there on DIY drug-induced comas ? Or , “Hibernation for Humans” ?Somebody wake me up on the first day of Spring , 2021.

        1. sgcox says:

          Be careful what you are wish for..

        2. Dark Day says:

          There’s always propofol, but don’t expect to have much of a mind left when you come out of it (if you do).

        3. In Vivo Veritas says:

          I strongly recommend the book “My Year of Rest and Relaxation”, by Ottessa Moshfegh, in which the protagonist attempts exactly what you suggest.

    2. chemist says:

      The Democratic party refused to peacefully transition power after the 2016 election by illegally conducting electronic surveillance on the Trump campaign, with FBI agents texting amongst themselves they would “stop Trump.” The FBI inserted intelligence assets in Trump’s campaign to try to plant a “Russian collusion” hoax which also failed. Sorry, but the Democrats have voided their right to exist as a political party. In 2020 alone, Dem governors tanked their state’s economies and made millions of people unemployed, they have allowed riots to go on for months in their craphole cities like Seattle and Portland, and here you are blaming Trump? Just how divorced from reality can you be?

      1. Steve says:

        Horse manure. It wasn’t “illegal” it was approved by a court so stop spreading lies.

        1. John Stamos says:

          It was found to be improperly approved by those courts based on improperly handled and altered documents as detailed in the Horowitz report.

      2. Philgro says:

        It makes me sad to think there are people who actually believe what you wrote are a factual summation of real events.

        1. steve says:

          Again, horseshit.
          “The Justice Department’s inspector general, Michael Horowitz, testified before the Senate Judiciary Committee on Wednesday about his report on the origins of the FBI’s probe into the 2016 Trump campaign’s possible ties with Russia.
          The 400-plus page report, released Monday, found that the FBI had ample evidence to open its investigation — despite allegations of political bias.
          n response to Democrats on the panel, Horowitz said his office “certainly didn’t see any evidence” in FBI or Justice Department files that former President Barack Obama asked the U.S. government to investigate Donald Trump’s campaign, as Trump has charged….
          Nor, Horowitz said, was there any evidence that the Obama administration tapped Trump’s phones at Trump Tower.
          Horowitz also reaffirmed that the so-called Steele dossier, a collection of partly unverified reports about then-candidate Trump, “had no impact” on the bureau’s decision to open the investigation.
          .

      3. Bob W. says:

        “…riots to go on for months in their craphole cities like Seattle…”

        After living in and around Seattle for about 70 years, it has been a wonderful place to live, with kind and civic-minded people, one of the more civilized and decent big cities in the US.

        There are a few square blocks east of downtown where wild-eyed Man-The-Barricades-For-The-Coming-Revolution-Which-Will-Be-Televised types hang out. This has been at times more or less true too of Paris, San Francisco, any number of cities that draw restless young people from everywhere else.

        I remember the era of the big riots and inner cities burning in the late 1960s. The actual level of damage and destruction now is practically nothing compared to that. But I believe that by comparison the political danger, of damage to democracy, is greater than it was then.

  12. Anon says:

    Perhaps a paradigm for future emerging viral diseases: 1) rapid deployment of mRNA vaccines to tamp down epidemics (ring strategies, etc that would be sparing to the vaccine supply) that provide good neutralizing Abs and CD4+ and CD8+ T-cell response, 2) roll out insect cell produced protein + adjuvant for broader vaccination and boosting in the future at lower cost and more volume.

    First round mRNA should not preclude boosting with protein (theoretically).

  13. Dude says:

    To sum up this post:

    There is no actual, material problem whatsoever, no evidence that any wrongdoing has taken place, and nothing has actually changed or is planned to meaningfully change at any agency, but here are some quotes from people I don’t like.

    Could have saved several paragraphs. Thanks for the update.

    1. Robert says:

      There’s two things that you can judge any President for: what they say and who they choose. So when you say that decisions will be made by you whether or not people who know talking about them think it’s a good idea, that seems sort of a substantive piece to judge Trump on, and something important to bring up.

      In general, what you say ought to matter – that seems to be what Trump and his people want to undermine, and the inability to trust what anyone says doesn’t lead anywhere that anyone lives in long enough to name.

      1. Dude says:

        >There’s two things that you can judge any President for: what they say and who they choose.

        You’re forgetting, rather hilariously, “what they do.”

        Count me in that group.

        1. Robert says:

          A President runs the executive branch – they don’t actually do much. Laws are passed by the legislative branch. Depending on the people in the executive branch (only some of whom he has control over), stuff gets done well or not. The economy is rather multifactorial. So what “they do” isn’t actually what you can judge – there are a lot of links between what they do and what happens. Hence the above – they control their personnel choices and what they say but not what they “do”. (They can choose to sign a bill or not, but don’t control the content, for example).

          There is also the possibility that you can’t know what they do – that things are classified and so you can’t connect what the President does and what results. So “what they do” is at best incomplete and at worse deceptive.

          And of course, what you say is still important.

          1. Dude says:

            You are offering a semantic dodge as an argument.

          2. Marko says:

            ” A President runs the executive branch – they don’t actually do much.”

            Listen to Trump’s speech on health care today , then throw those words between a couple slices of bread and enjoy your meal.

            He authorized drug purchases from Canada effective TODAY. He bought scads of senior votes with the $200 check he will shortly be sending to all Medicare recipients. He outflanked Biden and the Dems from the LEFT , something most would have considered impossible , but is actually unsurprising to those who’ve listened to what Biden says. If the Dems blow this thing, it’ll be well-deserved.

            Watch Trump’s poll results among seniors going forward. He’ll get a big bump from this , just from doing what Presidents have the power to do.

          3. Robert says:

            “Owning the libs” has kind of been Trump’s raison d’etre; the problem is, like most of his other policies, that it doesn’t really work for anything other than getting him elected.

    2. Derek Lowe says:

      Glad to help. But consider the fact that by the time you have identified an actual, material problem that it may be too late to do much about it.

      1. Dude says:

        I’ll keep my eyes peeled for five-legged dragons in my house, Reverend Parris.

        1. Shazbot says:

          “Look, just because he’s claiming absolute authority doesn’t mean he’ll abuse it.”

          No, the demand is unacceptable in itself.

    3. matt says:

      To sum up your post, you are simply too ignorant, perhaps willfully, to see the harms being done. “This is fine.” You have taken the blue pill.

      It’s ironic, to see the people who are most likely to use the pejorative “sheeple” about others, being themselves herded along by conspiracy theories and crackpots and trolls. Even foreign government manipulators have gotten into the action, because it’s so easy. Herded into creating the very things they profess to be afraid of and claim to fight against.

      In trying to fight a “deep state” (which in reality was people just telling the truth when the President was not, which offended him and was “hostile” to him), the President hires and places in power those whose primary loyalty is to him far above the truth or the American people or the Constitution. Not just those people–they then start firing subordinates (or the subordinates resign under unreasonable demands), and replacing them with likewise sycophantic drones and liars with hidden agendas. Hello, actual deep state.

      That’s not a partisan criticism. In the one hundred thirty years the civil service has been around, no President has assaulted it and tried to make it his personal echo chamber like this one.

      In no other administration I can think of would the head of the National Weather Service be threatened with termination for emphasizing that a state was not in the path of a hurricane, when in fact it was not in the path of a hurricane but the President had misremembered some information from a couple days back and said it was. No other administration would have demanded the head of the National Weather Service change his statement, rather than just having the President say “oh, I misspoke, here is the correct list of states in its path.”

      Similarly, the “swamp.” More convicted felons, more morally repugnant actors, more shady individuals than any previous Administration, more nepotism, more conflicts of interest and straight-up profiting from office–Harding would be envious–and yet the claim he’s been draining the swamp. Like Putin ridding Russia of corruption, maybe. It’s not corruption if the boss is getting his “fair share.”

      1. Dude says:

        “A vaccine might be approved by people I don’t like! Somebody save us!”

        1. Charles H. says:

          How about “A vaccine has been approved by people who lie more often than they are honest.”? Do you still trust it?

          That’s a real problem for me. I really want a vaccine, but I don’t believe a word that this administration says, because they lie so frequently. So how can I trust them when they say a vaccine is safe?

          Personally, I’m planning to wait until some other country approves it, and perhaps to investigate what results they report. And I generally take vaccines without worrying, because they’re normally trustworthy.

          1. Dude says:

            >That’s a real problem for me. I really want a vaccine, but I don’t believe a word that this administration says, because they lie so frequently. So how can I trust them when they say a vaccine is safe?

            This is literally what every single anti-vaxxer says. Congrats, you are now part of the problem.

    4. David says:

      “There is no actual, material problem whatsoever,….”

      Wrong. FDA approved 2 treatments on shaky evidence (hydroxychloroquine EUA was revoked, the second was convalescent plasma). The FDA commish made a promotional statement about convalescent plasma that over-stated efficacy (“35% reduction in mortality”) based on a post-hoc analysis of a subgroup from a non-placebo controlled trial. The CDC has posted controversial recommendations, and then reversed course, without transparency and with the appearance of political pressure. The MMWR has been “edited” by political hacks to change content in a direction not supported by science.

      The harm is evident. Bad leadership leads to bad behavior. Many in the population refuse to wear masks. Many have doubts about whether to trust a vaccine. Public trust in previously respected agencies has plummeted. America’s ability to protect the health of its citizens has been undermined, and 200,000 have died. Many of those deaths were preventable.

      1. John Stamos says:

        On the contrary, it sounds like those agencies worked exactly as designed. The FDA revoked its EUA for hydroxychloroquine as further evidence emerged and no one politically interfered to restore its EUA. AFAIK the jury is still out on convalescent plasma?

        This whole conversation is so funny to me. People are frightened at the notion of authoritarianism thanks to the idea of political control of a scientific organization. That is actually ANTI-authoritarian because the politician responsible for HHS (Trump) can (and will be) held accountable via an election. He has an incentive to not screw up.

        If a random (evil republican, for effect) scientist was in an untouchable position as head of an agency that could approve or deny drugs without ANY political oversight, how is that better? It isn’t!

  14. Derek,

    I agree that the Trump administration’s communication is fraught, largely unhelpful, and undermines the legitimacy of the FDA and CDC at just the wrong moment. All very bad things.

    I disagree that Secretary Azar’s memo represents something substantively new, as opposed to how and when it was communicated (definitely include President Trump’s bloviating in “how”!).

    Recall the 2011 non-approval of OTC Plan B contraception regardless of age: President Obama’s Secretary of HHS, Kathleen Sebelius, overrode the considered decision of FDA Commissioner Hamburg and CDER. Obama said at the time, “As I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old going into a drugstore should be able — alongside bubble gum or batteries — be able to buy a medication that potentially, if not used properly, could end up having an adverse effect. And I think most parents would probably feel the same way.” A policy decision overriding a technical decision. We may agree or disagree with that policy decision, but in a nutshell that’s why we elect a President, in preference to choosing to be ruled by unaccountable (to the voters) technocrats.

    That decision was later reversed in federal district court. Judge Gorman wrote that the Obama administration decision was made in “bad faith and improper political influence,” and that “it is hardly clear that the Secretary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious, and unreasonable.” Sound familiar?

    In my view, this was judicial overreach: Sebelius had the authority, and her reasoning — Teva’s lack of data on, as Sebelius put it, “all females [especially the very young] of child-bearing potential” — was anything but arbitrary, capricious, and unreasonable. Obama’s Dept. of Justice appealed, and lost in 2nd circuit appeals court. Teva also submitted more data to address Sebelius’ concerns. The rest is history: Plan B is now available, OTC, regardless of age.

    My larger point is that the President is the ultimate responsible person. Then the HHS Secretary, then the FDA Commissioner, both of whom are nominated by the President and confirmed by the Senate. They can — at any time and for any reason — be fired by the President and replaced, particularly if they are not implementing policies the *President* him/herself sets and articulates. After all, neither the Secretary nor the Commissioner are elected…but the President is, as are the Senators.

    The ultimate check on this (sometimes raw and ugly) exercise of power is the People — either by impeachment (via their elected Representatives and Senators), or at the ballot box (to vote out the President and/or the Congress). All these points were made by Attorney General Barr last week.

    This is basic civics (which I know *you* know, but is apparently not taught anymore).

    1. J N says:

      I am suspicious of anyone who has Azar’s condescending, obviously patronizing, disingenuous speaking tone.

      “Suspicious” isn’t strong enough. Actually, I assume that everything coming out of his mouth is intentionally deceptive.

      Probably, from time to time, it’s not.

      I don’t even bother considering the substance of what he says. IMO it’s a trap. Maybe I’m superficial.

    2. matt says:

      What’s new is not making the political decision, what’s new is corrupting what the scientists are allowed to tell the public about what the science says. (Granted, there were glimmers of this regarding climate science under the Bush 45 administration, but again for the most part they were trying to shape the political conclusion, not the underlying data.) What’s new is corrupting the vital statistics information compiled by the CDC so that even the numbers, the straight counts of who died by what cause, cannot be trusted. Do excess deaths demonstrate that COVID-19 deaths are not being overcounted? Get rid of excess deaths (or delay the counting of them).

      Are businesses being held legally accountable for negligence if they don’t take reasonable precautions against transmitting COVID-19 at their establishment? Change the CDC’s recommendations to remove as many precautions as possible. Does the President want schools to re-open? Change the CDC’s recommendations to say that schools should re-open.

      Did NOAA or NWS contradict the President concerning the path of a hurricane? Force NOAA to justify what the President said, and force the NWS to say he was right.

      Does the President want the stock market to soar? Squeeze the chairman of the Fed to ease monetary policy until the diarrhea of money has people bidding up the stock of a company entering bankruptcy. Or buying Inovio stock haha. Does the President want to tout his employment numbers? Make them so at the Dept. of Commerce.

      Every previous President has understood it is more valuable to have impartial data and impartial agencies, like unemployment numbers and vital statistics and weather information and an independent Fed and FDA and CDC, than the occasional inconvenience of bad numbers that don’t make you look good. And yes, elected officials have the final say on what to do about them, but if they meddle too much in the independent agencies, they ruin their ability to be useful. This President does not have that understanding.

  15. Eric Jacobsen says:

    The other day the health director of LA County, Dr. Barbara Ferrer had the scientific prescience, to know that LA County schools should not reopen until after the election. Concern about ulterior motives amongst those in high places is not entirely out of place.

    1. Carleton says:

      This illustrates the problem inherent in getting your news from Fox. Ferrer was asked whether it was likely schools could fully reopen by election day, given that they also serve as polling places. It made perfect sense that she mentioned election day in her answer, but Fox manipulated the quote to make it sound like she was playing politics.

  16. Alsadius says:

    Honestly, I think the biggest problem with political interference is that there hasn’t been enough of it. Not because I like Trump, but because the public health agencies are getting this so astonishingly wrong that almost any interference that results in them being bypassed is a net win.

    And this is global, not just the FDA and CDC. The complete gong show of masks, the fact that the CDC took six months to say it was airborne(and then walked it back immediately!), banning tests for being less than maximally effective, the lack of challenge trials, the fact that we still don’t know some really basic stuff about the disease, the fact that political protests get a totally different medical standard than any other form of gathering…I could go on, but it’s depressing.

    Yes, Trump only wants a vaccine out by November 3rd to win the election, obviously. He’s a gold-plated totalitarian gorilla. But what does it say about our public health agencies when they’re doing even worse on a lot of these questions than the gorilla?

    1. Dude says:

      Well said.

      The insane, comical, ridiculous standards for Covid testing in February/March stick out in my mind. Went to the doctor with breathing problems in early March and was told that I was only at risk of having Covid if I had days of fever and recent travel to Wuhan. All I could think of was “how is it that I know more about this than you?”

      And then, of course, “No evidence of human to human transmission” – WHO, January.

      Really nailed it, WHO.

      1. matt says:

        Regarding what the WHO said in January, you are simply ignorant and parroting a line. There is a standard check-list for infectious diseases, and you start by assuming nothing, and looking for evidence. Some people have an infection that causes respiratory problems, check. We’ve isolated a virus that seems to be responsible, check. It’s never been seen before, check–a new disease. Did they get it from animals? Well, they were at an animal meat market. Likely zoonotic infection, then. Check. It seems to have jumped from animals to humans, but has it jumped from human to human? Well, we haven’t seen that yet, every patient so far seems to have been at the market.

        That was where we were, or thought we were, in January. The WHO was repeating what the Chinese government spokesperson was saying, and the Chinese spokesperson was learning _that day_ that one or two Chinese researchers had recently observed and rushed to publish a paper on human to human transmission.

        That’s how these things happen, you don’t read about it in a textbook, some doctor in some hospital notices something, or some epidemiologist gets told an important piece of information (but stops to publish it for a nice monetary bonus before notifying authorities), and it’s a madhouse because people are getting sick and dying and the authorities never seem to be doing enough.

        The WHO wasn’t responsible for any of that, because they act only on the invitation of the local government, and they hadn’t been invited yet.

        1. Dude says:

          My take is not ignorant: I’m highlighting how dangerous and damaging the anecdote “absence of evidence is not evidence of absence” (ie, in response to the WHO’s tweet) can be when it comes to infectious diseases. I remember reading early articles about a strange pneumonia-like illness in Wuhan in late December afflicting an unknown number of people. Is one seriously supposed to believe that dozens to hundreds of people, enough to make international news, caught this illness zoonotically, without medically observable confirmation of human to human transmission? Of a _respiratory_ illness?

          It boggles the mind how completely many have exported all their sense to technocrats.

          Moreover, you prove OP’s point: you allude to a “standard checklist” which involves starting under totally blind assumptions about the nature of an infectious disease. State and fed agencies, multiple teams, and multiple hundreds of (unelected) MPH’s went down this “standard checklist” over a period of weeks to months, waiting for evidence, while the pandemic spread unchecked, and produced nothing but directionless tweets telling us to wash our hands and not be xenophobic, in part because their job didn’t depend on actually controlling the disease, but instead on simply going down checklists, just like they were taught.

          Look at exactly where that got us…

          1. matt says:

            The WHO was not saying coronavirus would not exhibit human-to-human transmission. No claim of evidence of absence, just a statement about absence of evidence. They were saying, as one usually says in that stage of the process, we have not yet seen evidence of human-to-human transmission. It is understood that when you have seen five cases, the sixth may be human-to-human transmission, but you don’t assume that to be the case until you see it. You don’t assume this is the Andromeda Strain or the Black Plague until proven otherwise, you just walk down the checklist of what you know so far. And again, the WHO was just passing along what the Chinese health authorities were saying, as were the CDC and news organizations and everyone else, because that’s all we had.

            Lots of people get salmonella poisoning, but not from human-to-human contact. Same for malaria, Zika. Avian influenza is not known to have sustained human-to-human transmission, but does have respiratory symptoms. The original SARS did transmit from human-to-human, but relatively poorly.

            Just because you don’t have a lot of experience identifying pathogens and distinguishing where they are coming from and how they are transmitted does not mean no one else does, either, or that their process is stupid because in hindsight it’s perfectly clear to you what they should have magically known from the start. It’s so obvious, isn’t it, to buy Amazon stock in 2000? _Of course_ people should have known to buy stock in the company of the wealthiest man in the world!

            Researchers aren’t making assumptions about disease, they are cataloging evidence. What they AREN’T doing is assuming. There’s a standard process, not because of assumptions–unless you consider Occam’s Razor an assumption–but because of the way the evidence presents itself. You can’t know there’s a problem until you run across a sick person. You can’t know it’s a virus until you have enough evidence from multiple patients that the virus is the connecting factor. You can’t know about transmission until you talk to patients and families of patients, and that doesn’t automatically happen when you go to the doctor. Especially if the person in the hospital is in respiratory distress and put on a ventilator. Epidemiologists have to get involved, and they have to start getting the list of patients and finding their families and asking about where they had been, etc.

            You blame people waiting until they find evidence…what, exactly, do you think should have happened? Do you think you should have been confined to your house in January 2020 just in case the virus exhibited human-to-human transmission, and just in case asymptomatic spread of the disease was happening? Would you also happily have accepted home confinement for Ebola, the original SARS, Zika, etc, “just to be safe” while we assembled evidence about how they were transmitted? There’s a reason why people don’t jump to conclusions. People are already mad enough about the social distancing required WITH evidence it’s needed, trying to enforce it without any evidence would never work.

            The epidemiological process wasn’t the problem here. The CDC did fumble creating the “US canonical test” for the virus, which was very costly to the US. But the major mistakes were political ones.

            One was not realizing how critical that test was for stopping transmission early, and focusing the CDC around getting it done and done right (sending candidate test kits out by standard mail? Are you kidding me? Weeks wasted waiting for the mail to arrive. How many lives could have been saved by next day air?). Another was thinking that reducing flights to that part of China was some sort of gutsy call that would save the day.

            Another was not taking a look at the national stockpile and assessing supply levels. (That was on the checklist of national pandemic preparedness–make sure you have enough PPE. Guess that would have been a good thing to have done, right?) Trump wants to blame other administrations, but he’s been in office for 3 years, and he was being told the virus could be bad–he had the opportunity to get things done, and instead he just blames.

          2. Marko says:

            ” You blame people waiting until they find evidence…what, exactly, do you think should have happened? ”

            I despise Trump , but I’m not going to pretend the WHO hasn’t completely botched their communication strategy. It’s not just on community transmission , but also on masks , aerosol transmission and other aspects , that they’ve locked themselves into the “no convincing evidence” roundabout , with no dignified way to exit.

            A simple communication strategy , consistent with both the evidence at the time and the importance of the precautionary principle when dealing with a potentially serious global pandemic , would sound something like this :

            ” Although the evidence is not conclusive , it is suggestive enough that it would be prudent to assume the following , and act accordingly to the best of our ability , until further evidence proves otherwise :
            1. Community transmission may be occurring
            2. Masks help protect both you and others
            3. Aerosol transmission may occur in certain settings , particularly indoors , and it may be as significant , if not more so , than fomite transmission ( for which we also have limited evidence , but for which we have nonetheless encouraged you to wash your hands every ten minutes ) “

          3. WST says:

            “just a statement about absence of evidence. ” but the effect was that the testing rules ruled out getting evidence of lateral infections.
            The community infections in Italy and France were detected by doctors that chose not to follow the rules (according to press stories).

        2. Duane Schulthess says:

          “ The WHO wasn’t responsible for any of that, because they act only on the invitation of the local government, and they hadn’t been invited yet.”

          So that makes it OK that the WHO sent out a communication to several million people that the virus had no evidence of human to human transmission, without evidence, on January 14th? We’re all supposed to give them a pass on this? I’m sorry, I vote no on that.

  17. J N says:

    Why does Trump, or anyone at the White House, think that his already anti-vaxxer base is going to want a politically approved vaccine, which is precisely “freedom lovers” have been complaining about since roughly Gerald Ford?

    Is the idea to drive down the street in white vans, have “camo shirts” yank people off the sidewalks, and jab them in the shoulder?

    As Derek mentioned in his tweet, the “tortoise” vaccines have the aura of better candidates anyway. And for various reasons including the above, I am likely to be one of those people who wanders around in a mask for quite a while, perhaps even after getting my arm stuck or my nose squirted or swallowing a sugar cube.

    2020 started off on the crazy track and immediately left the rails.

    1. Dark Day says:

      We’ll all be masked for a while after a vaccine rolls out. Even the best-case scenarios have a widely accessible vaccine by early summer at best, and a return to “normal” life several months after that. Given the logistical hurdles of distributing and actually administering the vaccines, I’d be very surprised if things went smoothly even if they did get started that early. (And, of course, if it’s a vaccine that requires two doses a month apart, AND if it then requires at least an additional month for it to begin to work. that’s twice the number that have to shipped, and another couple of months for each person to wait for any meaningful immunity to kick in.

      I hope very much that Fauci’s prediction that we’ll start to feel safe going back into theaters unmaksed by “late in 2021” comes to fruition, but it wouldn’t surprise me at all if it were early 2022 before we really felt free and out of the woods with this. Of course, with any luck at all, things will begin improving incrementally well before then — maybe some of the masking restrictions can be modified (if I’m not mistaken, New Zealand requires them on trains and buses, but not outdoors), maybe groups of over 50 can gather, etc.etc.etc. — but I’m pretty sure it will be a very gradual process. And, of course, it will depend on those numbers –deaths, serious / moderate cases, etc. — and how they’re interpreted by public health officials, who will probably choose to err on the side of convseravitsm when it comes to loosening up restrictions.

      1. confused says:

        I think you’re underestimating how quickly people will “snap back” once they’ve got a vaccine.

        Nor are public health officials likely to have much actual influence in what happens if public opinion is strong enough in one direction. Some cities (like NYC and others that were hard hit early) maybe. But I can’t see that happening in most of the US.

        If there is not a strong fall wave then COVID will likely no longer be at the top of the public consciousness after November 3, IMO.

        1. J N says:

          I think the perception of “got a vaccine” is the problem here.

          This is very, very unlikely to happen on or around November 4, even if someone in the White House says or has said “we got a vaccine,” because:

          * Only one vaccine has a chance to have a readout by that date,
          * There won’t be much to go around and/or that is able to be got around,
          * There won’t be many people of any political persuasion who want that thing and/or people who are going to consent to mandatory vaccination,
          * The early candidates will need boosters and won’t provide strong immunity right away, and
          * The early candidates probably won’t be “very” efficacious

          So “herd mentality” is probably not going to cause people to rip their masks off on November 5.

          1. confused says:

            Sure, I meant “once people have received a vaccine they will have no patience for social distancing” not “once a vaccine’s approval has been announced”.

            Although if all the high-risk people get vaccinated, a lot of younger people might say, well, now I’m not going to infect one of them and I’m not really worried about it for myself…

            So no, not in early November. But I think there is very little chance of meaningful social distancing existing next summer in 99% of the US.

        2. Dark Day says:

          It’s not about what people will or won’t “accept.” It’s not even about what public health officials do or do not manate. It’s about what the virus DOES.

          We’ve already seen what happens when people “don’t accept” warnings and so act carelessly, whether out of defiance (the hard-core anti-maskers) or misguided optimism in areas where the “curve” seemed to be “flattening,” so folks let down their guard. If that happens again, we will likely see a return to something a lot closer to where we are now than to any “normal” that any of us would be able to envision.

          1. Dark Day says:

            Dr. Fauci seems to be saying something very much like this already (hard to tell whether he’s talking relatively short-term here, or whether he’s predicting that it’s going to be this way for the the foreseeable future, even after a vaccine rollout — in which case, so much for his earlier predictions of “normalcy”!) . . .

            https://www.cnn.com/2020/09/24/health/us-coronavirus-thursday/index.html

          2. confused says:

            That can only go on so long, though. If there’s a pattern of successive “waves” sooner or later herd immunity is reached.

            And heterogeneity… if most of the potential super-spreaders have already been infected there may not be much potential for explosive growth anymore (except in really remote places not hit hard yet, like the northern Great Plains states now).

            But even without that… my fundamental point is, sooner or later the majority of the population will be so tired of this that they will just accept a higher rate of deaths/higher personal risk as the “cost” of going back to more or less normal.

            COVID won’t be “new” long, and so it will become less scary. Plus treatments will improve & immunity levels will rise, so deaths will likely go down even before the vaccine. Currently reported deaths are still largely from the summer surge in TX FL CA etc.

            If a vaccine is distributed by, say, February or March (after an approval in maybe Nov or Dec) practically everyone will be ready to accept that as “the end”.

          3. Dark Day says:

            ” . . .sooner or later the majority of the population will be so tired of this that they will just accept a higher rate of deaths/higher personal risk as the “cost” of going back to more or less normal.”

            I sincerely hope this does not happen. It will translate into, “Well, it’s just THOSE PEOPLE [e.g., the elderly, minorities, poor folks, whoever] who are dying, so why should WE care?” Do we really want COVID to take its place alongside drug addiction, street crime, inadequate education and housing, malnutrition, and a host of other social and physical maladies as a “ghettoized” problem, tacitly accepted as “normal” or “inevitable” because it’s not perceived as affecting the day-to-day lives of the “mainstream”?

          4. confused says:

            Who said anything about “want”? I think it will happen because our perception of risk often has little to no correlation to actual risk.

            And I don’t think the economic/social disparities in COVID risk will be nearly as strong, if they persist at all, after the social-distancing era. I’ve seen at least one paper suggesting this is an infection-rate difference, not fatality-rate… IE it’s due to reduced ability to social-distance (e.g. ability to work from home, living conditions). When no one is social-distancing that won’t last.

            Age of course will still have a huge effect…

          5. Michael says:

            Dark Day, re Fauci’s comments yesterday, I think he was saying that public health measures will need to be in place even when nationwide doses are available, which is why he thinks normal socialization won’t be the case in the spring. He elaborated:

            “This means that in theory you could immunize everyone by then, but in reality the logistics and practicality of immunizing people will likely be until the second, third or early days fourth quarter of the year, when we get back to normal.”

          6. Dark Day says:

            Michael, given Fauci’s other recent comments, I tend to agree with you. My larger point, though, that we’ll be masking and distancing, at least to a significant extent, for some time after a vaccine is rolled out, still stands. And, as g*ddam tired of this as I am, I’m glad that’s the case — I want to share smiles, hug my friends, and gather together in celebration again so badly I can’t stand it — but I’m willing to wait for as long as it takes, to be able to do so safely. If we let our guard down and try to be too “normal” too soon, we can only move backwards.

          7. Michael says:

            Well, Dark Day, if a safe and effective vaccine is rolled out, it won’t move anything “backwards” if people let their guard down while unvaccinated or around unvaccinated individuals. It’s just a less safe way forward. One way or another, we will progress to a place where the general public does not have the susceptibility of being completely naive to the virus. Better that most get there through a good vaccine rather than through contracting the virus.

  18. Bill says:

    Trumpers vs Haters. Haters vs Trumpers.

    This blog is now fit for Reddit.

  19. Blaine White, M.D. says:

    Surely the role of FDA and CDC in the U.S. Covid-19 debacle argues against utilizing their positions as any final authority IN EMERGENCIES. Bureaucracies are useful for longer scale regulation, but they are lousy in emergencies. I categorically reject conspiracy theories. But my dad worked in FAA air-traffic control and then administration for 42 years, and I know that big bureaucracies tend towards expensive and sometimes lethal mistakes. In the 1960s I watched as he struggled with the introduction of computers into air-route traffic control centers on top of the long-functioning VOR to VOR airways with aircraft separation managed by their time on position and “ident squawk” to basic radar. It was a circus and a corporate feeding frenzy. It wasn’t that upgrading the control infrastructure didn’t need done; it was rather that the ponderous and conflicting nature of the bureaucracy was inherently chaotic for trying to make rapid progress by spending billions on multiple bidders whose ideas needed to work in a unified crucial mission. Such bureaucracies are not only poor at managing disasters, they can evolve them, like having manufacturers largely self-certify large passenger aircraft.
    In an emergency the requirement is strong KNOWLEDGABLE central leadership, CONSISTENCY, and acceptance of RESPONSIBILITY. I don’t hate Trump, but he does not operate on any of those three principles, and he was unable to identify and empower such a leader (Pence was not it) and then shut-up and own the results. That process is NOT A COMMITTEE; it is leadership. Dr. Ron Krome was a national leader in the emergence of the specialty of Emergency Medicine in 1979 and was the founding leader of Detroit’s Wayne State University Emergency Medicine programs. He kept on his desk an engraving that said, “For God so loved the world that He didn’t send a committee.” Donald Trump would have either learned that or washed out of an Emergency Medicine residency for saying, “I’m not responsible.” Instead, the resulting chaos in both failed acceptance and communication of the seriousness of the situation and a series of inept decisions (starting with testing kits) and conflicting statements from the administration and its agencies has put us where we are at with far too many lives lost. There is no reason to believe this will resolve in the vaccine rollout.

  20. Michael says:

    Thanks, Derek, for a terrific blog. Reading it in Australia, I would simply note that in the past, approval of a vaccine by the relevant authorities in the USA would have been seen by those of my compatriots who take an interest in such things as compelling evidence of a vaccine’s acceptable safety. But I’m by no means sure that that’s still the case. I’m of the generation which accepted the manifest benefits of vaccination without question, and have been vaccinated against just about everything that moves. But the risk of politicisation of everything coming out of USA officialdom these days, combined with the inherent risks of an expedited development process, will make me inclined to hold back a bit in this case.

  21. Dark Day says:

    I just had a[nother] troubling thought: If Trump lost the election and hadn’t been able to get a vaccine approved for EUA before Election Day, could he simply throw a hissy-fit, cancel the remaining “Operatoin Warp Speed” funding, and let the whole attempt to expedite the development and distribution of a vaccine die on the vine?

    1. SteveM says:

      Why don’t we just forget science on this blog and simply conjure up pathological Trump Hate “What if” scenarios?

      A lot more fun and the contrived “troubling” story lines are open ended.

      1. Dude says:

        “We need to trust our scientific agencies, and Trump supporters need to stop listening to conspiracy theories!

        …But is anyone else worried that if Trump loses the election that he might order the CDC and FDA to nuclear bomb all vaccine facilities just to spite the free world as he embarks on a galactic ethnic cleansing mission to install himself as overlord of the universe from a white nationalist base on Mars? If you read between the lines of this random press release from the NIH….”

      2. navarro says:

        “Why don’t we just forget science on this blog and simply conjure up pathological Trump Hate “What if” scenarios?”

        unfortunately the behavior of the president has already gone so far that it’s hard to discern the difference between reality and pathology. and in its rejection and/or obfuscation of relatively clear science the republican party as a whole has not behaved much better.

  22. Ken says:

    https://www.cnn.com/2020/09/24/politics/michael-caputo-cancer-diagnosis/index.html :

    After undergoing surgery last week at the National Cancer Institute in Bethesda, Maryland, doctors diagnosed Caputo with “squamous cell carcinoma, a metastatic head and neck cancer which originated in his throat,” the spokesman, David DiPietro, said in a statement.

    Might this explain Caputo’s behavior?

  23. Tom says:

    Derek –

    I just wanted to say keep up the good commentary on the whole messy situation the Trump administration has created around this pandemic (and many other things IMO). I’ve been a long time reader (and a very, very rare commenter) and I’ve noticed that some of your more regular commenters have stopped posting recently, leaving behind an influx newer more aggressive political comments. Happy to see debate where it is due, but not so much some of what people say nowadays.

    So in a nutshell, thank you for your efforts!

    1. Shazbot says:

      Most of the regulars are smart enough to stay well out of the fray here.. this blog is just slammed with the usual pro-Trump disinfo present to distract and dismay people. A thousand off-topic excursions to desperately change the subject from whatever well-reasoned, well explained, well documented post heads up the comment thread.

      Don’t worry, they’ll be back for the more science-heavy articles.

      And yes, thank you Derek

      1. DataWatcher says:

        I do think it is legitimate here to discuss the implications of the Trump administration’s behavior on the potential success of a vaccine rollout and eventual uptake. If those discussions occasionally get a little bit over-passionate, that only reflects the urgencey of the situation. On the other hand, I would agree that ad hominem attacks and political rants that don’t focus on the particular issue at hand are not appropriate in this forum

    2. Derek Lowe says:

      Things will gradually get back to normal eventually!

      1. Michael says:

        For mental health reasons, I am thinking of ordering a pillow embroidered with “Things will gradually get back to normal eventually!” for my couch.

      2. Charles H. says:

        Things will get back to normal? Well, yes, if you calculate “normal” with a moving average. But the normal returned to won’t be very similar to the normal before hand. (There are lots of reasons..but one of them is:) Society is not stable, it’s at best multi-stable in a large number of dimensions. Along some of them it takes a larger push to shove things away from the meta-stable position than along others. Even if nothing happens, some of the dimensions have such a low transition threshold that “thermal noise” will eventually cause a transition. This year has seen a high degree of excitation along multiple axis…and the relaxation will not yield a result that similar to the preexisting state. Predicting exactly *what* the new metastable state will be, though, isn’t going to be very accurate. Probably the best that can be done is to select the desired transitions and to pull in that direction…and hope for the best. Unfortunately, sometimes those “desired states” are quite close to extremely undesirable states. (You could probably model this with chemical state transitions, but I’m a programmer. Still, think of it as a thermodynamic equilibrium.)

        1. Marko says:

          Take legitimate and effective institutions as one example of a “desirable state”. Now , what is the final equilibrium state of such an institution in the absence of any energy-requiring reactions effecting them ? A pile of rubble , as the law of entropy demands. Left alone entirely , institutions will slowly crumble. It takes active work to maintain them , much less improve them.

          Institutions have been allowed to slowly decay across multiple administrations , but under Trump , the dynamics are different. Trump is like an enzyme – a biological catalyst – that speeds up the attainment of institutional equilibrium in its final , collapsed state.

          Trump has multiple enzymatic activities , each of which seem to be directed towards a different “undesirable state” equilibrium endpoint. Given this country’s feckless leadership across the political spectrum , along with our unprecedented debt burden and decreasing standing on the global stage , recovery of the “desirable states” that we all want will not happen any time soon ( if ever ) even after Trump is gone.

          The “new normal” may well be rubble as far as the eye can see.

  24. Chris Phoenix says:

    All the times I heard people say, “Trump is putting his people at the top, but all the career bureaucrats will keep things on an even keel”? This appears to have erased all that.

    All the policy-making authority that Congress has delegated to those career bureaucrats, for decades? All that accumulated authority is now directly in the hands of a Trump person.

    Whether you’re elated or horrified depends on which news channel you watch. TLDR: Trump just owned the libs quite thoroughly.

  25. Steve says:

    We are witnessing what happened in Germany in the 20’s. If Trump gets re-elected, or worse if he corrupts the system to obfuscate the results and declares martial law which is increasingly likely – we the will be witnessing Germany in the 30’s.

    1. confused says:

      The US has a much, *much* longer history as a republic than Germany of that era (which had been a monarchy as recently as WWI) and the rest of the situation is not at all similar (Germany had just lost WWI and was dealing with the consequences of that).

      The US’s republic/democracy has survived huge disruptions far worse than what we are seeing today (the 1876 election dispute happening in an era even more polarized than today, 1918-19 pandemic, Great Depression, and even the Civil War) and attempts to seize power by people much more competent and charismatic (think Andrew Jackson).

      The US becoming a dictatorship is incredibly improbable.

      Nor is it actually that easy to steal an election from the federal level, most of it is done by the states rather than the federal government. This is very unlikely to be a 2000 situation where it comes down to 500 votes in one state with a poorly-managed election and there is genuine uncertainty.

      1. steve says:

        The parallels are quite similar, unfortunately, despite your optimistic viewpoint. “”The Nazis, in Hett’s account, were above all “a nationalist protest movement against globalization.” Even before the Great Depression brought huge unemployment to Germany, the caprice of the global economy offered an opportunity to politicians who had simple answers. In their 1920 program, the Nazis proclaimed that “members of foreign nations (noncitizens) are to be expelled from Germany.” Next would come autarky: Germans would conquer the territory they needed to be self-sufficient, and then create their own economy in isolation from that of the rest of the world. As Goebbels put it, “We want to build a wall, a protective wall.” https://www.nytimes.com/2018/06/14/books/review/benjamin-carter-hett-death-of-democracy.html?fbclid=IwAR2Z1VwDmHleAqTv5TkR-8FRnKoAn-NewgS6TyyUYJJNK_8afrI4HbHNofc

        1. John Stamos says:

          Are you really trying to frame the German national socialist party as more in line with republicans, than people in the US who actually describe themselves as socialists and use the same tactics of class conflict and violent intimidation?

          Laughable…

          1. Steve says:

            Yes. You are confused. The Nazis were facists despite the name socialist. Please read some history before posting again.

          2. John Stamos says:

            “The Nazis were facists despite the name socialist.”

            Thank you for so concisely highlighting why folks don’t buy the benign message of groups who call themselves socialists today…

          3. FredBo says:

            Yes, it would be laughable, if you did not seem to suffer from a serious learning or educational problem. The fact that you cannot distinguish between socialists and fascists is concerning. Did you not attend school? Were you schooled so badly that you did not cover WWII in any depth? Do you have attention or other mental deficits which prevent remembering basic concepts? Are you particularly susceptible to neo-nazi propaganda?

            If you watch a lot of Fox “editorial content”, then it is probably the last, although that does also speak to a generally low aptitude.

          4. John Stamos says:

            @FredBo

            I’m a born and practicing Jew, read the Diary of Anne Frank, have been to Yad Vashem TWICE (look it up), and the American national Holocaust Museum, so yes, still laughable that you think I’m ignorant on this subject.

            I know exactly “the difference” between a socialist and a fascist: the socialist hides his fascism behind flowery slogans and benign promises of prosperity to gullible people like you.

            My people learned that the hard way, and we will never be fooled again. Ever.

          5. steve says:

            John Stamos – Spare me. I come from a family of rabbis. If you can support a white supremacist like Trump then you have learned absolutely nothing from our 4000 years of history. Go to Yad Vashem again and this time read some history and try to learn from it.

          6. seebs says:

            Well, yes? Basically similar positions on a number of issues, similar practices when dealing with “undesireables”, and so on. The “national socialist” party was not in any meaningful way socialist; political party names are usually pretty much meaningless.

  26. Miles A Peters says:

    Derek – if you have any more Komodo dragons, I can find some pet baskets full of small loud dogs to stuff them into…if it is not noisy enough already….

  27. A Kapoor says:

    @derek lowe
    1c for your thoughts on the Johnson & Johnson phase 1 preprint?

    https://www.medrxiv.org/content/10.1101/2020.09.23.20199604v1

  28. Steve Scott says:

    Sep. 25 update: Trump has lost patience with the head of the CDC for contradicting his rosy messaging
    https://www.cnn.com/2020/09/25/politics/redfield-trump-cdc-morale/index.html

  29. Erik Dienemann says:

    Derek – great, insightful post, thanks. I wrote the comments below elsewhere about the EUA legal aspects, mostly and thought I’d share it here, since I hadn’t seen the USC being discussed here.

    And here’s where it gets interesting, legally. Dr. Henry Miller wrote a really detailed, insightful article on this last week and he was the first one I saw point out the issues in the USC Code on EUAs, which predate any of this. There exists a loophole in the Federal LAw (U.S. Code, Title 21, Chapter 9, subsection c), that could be used unilaterally by Hahn’s boss, the HHS Secretary, Alex Azar, a political appointee and lawyer (not a scientist). The relevant section of the law, “Authorization for medical products for use in emergencies,” specifies that:

    “𝗧𝗵𝗲 𝗦𝗲𝗰𝗿𝗲𝘁𝗮𝗿𝘆 𝗺𝗮𝘆 𝗶𝘀𝘀𝘂𝗲 𝗮𝗻 𝗮𝘂𝘁𝗵𝗼𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝘂𝗻𝗱𝗲𝗿 𝘁𝗵𝗶𝘀 𝘀𝗲𝗰𝘁𝗶𝗼𝗻 𝘄𝗶𝘁𝗵 𝗿𝗲𝘀𝗽𝗲𝗰𝘁 𝘁𝗼 𝘁𝗵𝗲 𝗲𝗺𝗲𝗿𝗴𝗲𝗻𝗰𝘆 𝘂𝘀𝗲 𝗼𝗳 𝗮 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗼𝗻𝗹𝘆 𝗶𝗳, 𝗮𝗳𝘁𝗲𝗿 𝗰𝗼𝗻𝘀𝘂𝗹𝘁𝗮𝘁𝗶𝗼𝗻 𝘄𝗶𝘁𝗵 𝘁𝗵𝗲 𝗔𝘀𝘀𝗶𝘀𝘁𝗮𝗻𝘁 𝗦𝗲𝗰𝗿𝗲𝘁𝗮𝗿𝘆 𝗳𝗼𝗿 𝗣𝗿𝗲𝗽𝗮𝗿𝗲𝗱𝗻𝗲𝘀𝘀 𝗮𝗻𝗱 𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗲, 𝘁𝗵𝗲 𝗗𝗶𝗿𝗲𝗰𝘁𝗼𝗿 𝗼𝗳 𝘁𝗵𝗲 𝗡𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗜𝗻𝘀𝘁𝗶𝘁𝘂𝘁𝗲𝘀 𝗼𝗳 𝗛𝗲𝗮𝗹𝘁𝗵, 𝗮𝗻𝗱 𝘁𝗵𝗲 𝗗𝗶𝗿𝗲𝗰𝘁𝗼𝗿 𝗼𝗳 𝘁𝗵𝗲 𝗖𝗲𝗻𝘁𝗲𝗿𝘀 𝗳𝗼𝗿 𝗗𝗶𝘀𝗲𝗮𝘀𝗲 𝗖𝗼𝗻𝘁𝗿𝗼𝗹 𝗮𝗻𝗱 𝗣𝗿𝗲𝘃𝗲𝗻𝘁𝗶𝗼𝗻… 𝘁𝗵𝗲 𝗦𝗲𝗰𝗿𝗲𝘁𝗮𝗿𝘆 𝗰𝗼𝗻𝗰𝗹𝘂𝗱𝗲𝘀 (𝟭) 𝘁𝗵𝗮𝘁 𝗮𝗻 𝗮𝗴𝗲𝗻𝘁 𝗿𝗲𝗳𝗲𝗿𝗿𝗲𝗱 𝘁𝗼 𝗶𝗻 𝗮 𝗱𝗲𝗰𝗹𝗮𝗿𝗮𝘁𝗶𝗼𝗻 𝘂𝗻𝗱𝗲𝗿 𝘀𝘂𝗯𝘀𝗲𝗰𝘁𝗶𝗼𝗻 (𝗯) 𝗰𝗮𝗻 𝗰𝗮𝘂𝘀𝗲 𝗮 𝘀𝗲𝗿𝗶𝗼𝘂𝘀 𝗼𝗿 𝗹𝗶𝗳𝗲-𝘁𝗵𝗿𝗲𝗮𝘁𝗲𝗻𝗶𝗻𝗴 𝗱𝗶𝘀𝗲𝗮𝘀𝗲 𝗼𝗿 𝗰𝗼𝗻𝗱𝗶𝘁𝗶𝗼𝗻; (𝟮) 𝘁𝗵𝗮𝘁, 𝗯𝗮𝘀𝗲𝗱 𝗼𝗻 𝘁𝗵𝗲 𝘁𝗼𝘁𝗮𝗹𝗶𝘁𝘆 𝗼𝗳 𝘀𝗰𝗶𝗲𝗻𝘁𝗶𝗳𝗶𝗰 𝗲𝘃𝗶𝗱𝗲𝗻𝗰𝗲 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲 𝘁𝗼 𝘁𝗵𝗲 𝗦𝗲𝗰𝗿𝗲𝘁𝗮𝗿𝘆, 𝗶𝗻𝗰𝗹𝘂𝗱𝗶𝗻𝗴 𝗱𝗮𝘁𝗮 𝗳𝗿𝗼𝗺 𝗮𝗱𝗲𝗾𝘂𝗮𝘁𝗲 𝗮𝗻𝗱 𝘄𝗲𝗹𝗹-𝗰𝗼𝗻𝘁𝗿𝗼𝗹𝗹𝗲𝗱 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀, 𝗶𝗳 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲, 𝗶𝘁 𝗶𝘀 𝗿𝗲𝗮𝘀𝗼𝗻𝗮𝗯𝗹𝗲 𝘁𝗼 𝗯𝗲𝗹𝗶𝗲𝘃𝗲 𝘁𝗵𝗮𝘁 (𝗔) 𝘁𝗵𝗲 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗺𝗮𝘆 𝗯𝗲 𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗶𝗻 𝗱𝗶𝗮𝗴𝗻𝗼𝘀𝗶𝗻𝗴, 𝘁𝗿𝗲𝗮𝘁𝗶𝗻𝗴, 𝗼𝗿 𝗽𝗿𝗲𝘃𝗲𝗻𝘁𝗶𝗻𝗴 (𝗶) 𝘀𝘂𝗰𝗵 𝗱𝗶𝘀𝗲𝗮𝘀𝗲 𝗼𝗿 𝗰𝗼𝗻𝗱𝗶𝘁𝗶𝗼𝗻.”

    The article notes that the Secretary is “only required to consult with, but not obtain agreement from, the three subordinates specified in the law.” In a normally functioning government, there should be no way possible for the Secretary of HHS, who is not a scientist, to overrule the heads of NIH and CDC (it’s also odd that the head of the FDA is not part of that advice group), if their scientific advice is that an EUA is not safe to pursue and all of these folks are on record saying that politics will play no role in any EUA for any vaccine, but I certainly share the concern that there is a path to ignore such advice.

    https://geneticliteracyproject.org/2020/09/17/why-a-coronavirus-vaccine-october-surprise-could-be-an-october-disaster/

    This is a time when Americans and our scientists and politicians should all be on the same page, as we’re on the precipice of an historic breakthrough in vaccine technology, assuming one or more of these vaccines is safe and effective (which most expect), as nobody thought this could be done in under a year, let alone in under 24 months when this all started – and assuming we achieve this, this will likely be Trump’s biggest accomplishment of his presidency, as he was a huge driving force behind Warp Speed, but he can’t just let it go and keep quiet and let the scientists and regulators do their jobs. We should be celebrating this likely accomplishment, not arguing over how it might be deployed prematurely.

    1. Dark Day says:

      “This is a time when Americans and our scientists and politicians should all be on the same page, as we’re on the precipice of an historic breakthrough in vaccine technology, assuming one or more of these vaccines is safe and effective (which most expect), as nobody thought this could be done in under a year, let alone in under 24 months when this all started – and assuming we achieve this, this will likely be Trump’s biggest accomplishment of his presidency, as he was a huge driving force behind Warp Speed, but he can’t just let it go and keep quiet and let the scientists and regulators do their jobs. . .”

      That’s exactly the problem. Believe me, as much of a Trump-loather as I am (and have been since the beginning), I would be the first to credit him for a remarkable, historic achievement had he simply done what was necessary to get Warp Speed underway (although, like Fauci and others, I don’t like the name — I think it sends the wrong signals) and then just sat back and let the scientists control the discourse.

      But he couldn’t / wouldn’t do it. Instead, with his lies and obfuscations, his opportunism, his ad hominem attacks, and his seeming inability to see anything — even the health of milliions of Americans — through any lense but that of craven political self-interest, he has sullied and made toxic what could and should have been a truly historic ahievement.

      1. Marko says:

        We should empathize with Mr. Trump. After all , he paid $750 in taxes in both the 2016 and 2017 tax years , showing that he’s just a regular , working-class stiff like the rest of us :

        https://twitter.com/shearm/status/1310326157062086657

        If I ever get the chance , I’ll be happy to treat the poor guy to a beer…..

        USA! USA! USA!

  30. Fob Snow says:

    It is the massive failures of the career science bureaucrats at the CDC and FDA That got us into this situation. The “pro-science” crowd seems to have forgotten the failed testing kits, failed guidance on masks, and the FDAs failure to authorize university lab testing that led to the coronavirus Armageddon in the US. It makes perfect sense that the administration wants to rein the CDC and FDA given their initial response was so catastrophic.

    1. steve says:

      Fob Snow seems to forget that Trump lied about the pandemic over and over, as has now been proven beyond a doubt. And don’t tell me he did it to prevent “panic”. I mean really – the same guy who tried to whip up a frenzy about brown people escaping persecution saying they were invading out country bringing rapists and terrorists? That’s the guy who didn’t want panic? The guy who did NOTHING for the first five months of the pandemic when it was hitting blue states? That guy? Yeah, right. It was FDA’s fault. It was China’s fault. It was everyone under the sun’s fault except the incompetent ignoramus in the White House. But keep drinking the bleach, keep drinking the bleach.

      1. Steve says:

        Oh – and let’s not forget that he disbanded the Pandemic Response Team (because it was formed by Obama, of course), left CDC with over 700 open positions that he refused to fill and put someone widely viewed as incompetent in charge of it (never heard him do that with an agency before!). But yeah, he bears no responsibility whatsoever. The only buck that stops with him is the one he pockets.

  31. Oddstar says:

    “And doesn’t that mean that any FDA approvals or rule changes will have no force unless the Secretary sees fit to attach that signature? Giving that Secretary that power to overrule them as he or she sees fit? And even if that’s not the memo’s intention – and I’m not convinced that it isn’t – wouldn’t this seem to be a very funny time to be promulgating such a rule, what with so many people worrying about what has been obvious political interference in the work of the FDA and CDC?”

    You mean that the system might work the way it is supposed to, in accordance with the fundamental principles of democratic-republican governance? No bureaucracy is supposed to have rule-making power–that is, law-making power–outside of the control of politically responsible officials, in this case a cabinet secretary appointed by the President and confirmed by the Senate. I’m sorry you were unhappy with the outcome of the last election, but that’s how democratic-republican government works: sometimes the other side wins, and then it gets to govern.

  32. steve says:

    Oddstar – Wrong. Federal administrative agencies, when granted the power to do so in a statutory grant of authority from Congress, may promulgate rules that have force of law. Agencies “legislate” through rulemaking—the power to promulgate (or issue) regulations. The federal regulation of food, drugs, cosmetics, biologics, medical products and tobacco is legally mandated by acts of the United States Congress.

  33. steve says:

    And BTW, stop the both sides false equivalence. The idea that science is subject to the whims of whomever is in power is purely Republican in origin and has no equivalence among Independents or Democrats (or anyone of a rational bent).

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