Medicine Should not be Political

Or, more accurately, the president should not use false hope to try and bolster his political image.

Via the AP: FDA chief apologizes for overstating plasma effect on virus

Responding to an outcry from medical experts, Food and Drug Administration Commissioner Stephen Hahn on Tuesday apologized for overstating the life-saving benefits of treating COVID-19 patients with convalescent plasma.

Scientists and medical experts have been pushing back against the claims about the treatment since President Donald Trump’s announcement on Sunday that the FDA had decided to issue emergency authorization for convalescent plasma, taken from patients who have recovered from the coronavirus and rich in antibodies.

Trump hailed the decision as a historic breakthrough even though the treatment’s value has not been established. The announcement on the eve of Trump’s Republican National Convention raised suspicions that it was politically motivated to offset critics of the president’s handling of the pandemic.

It raised those suspicions for good reason, as it is transparently obvious that Trump is hoping for something, anything to rid himself of this troublesome virus. And he is willing to gamble (as he did on hydroxychloroquine) every time a possible treatment emerges because if it ends up working he can claim to have have been at the forefront of the solution. And if it ends up to be nothing, he can pretend for a while that it was great in the absence of counter-evidence and then he can forget he ever said it.

Trump has recently accused some FDA staff, without evidence, of deliberately holding up new treatments “for political reasons.” And Trump’s chief of staff, Mark Meadows, said over the weekend that FDA scientists “need to feel the heat.”

Ultimately this kind of behavior is damaging because it gives false hope while undercutting confidence in science (and in agencies like FDA that are not supposed to be partisan or even especially political). It helps create false realities for people to live in and his allies in some segments of the “news” industry will help him do it. It is corrosive.

FILED UNDER: COVID-19, Donald Trump, US Politics
Steven L. Taylor
About Steven L. Taylor
Steven L. Taylor is a Professor of Political Science and a College of Arts and Sciences Dean. His main areas of expertise include parties, elections, and the institutional design of democracies. His most recent book is the co-authored A Different Democracy: American Government in a 31-Country Perspective. He earned his Ph.D. from the University of Texas and his BA from the University of California, Irvine. He has been blogging since 2003 (originally at the now defunct Poliblog). Follow Steven on Twitter

Comments

  1. Scott says:

    Or, more accurately, the president should use false hope to try and bolster his political image.

    Oops.

    More seriously, noted scientist and epidemiologist Peter Navarro says:

    Navarro says need for randomized trial on plasma is a “crazy talking point”

    White House economic adviser Peter Navarro said on Tuesday that recommendations from health experts that convalescent plasma undergo a randomized trial as a COVID-19 treatment before receiving an emergency authorization are a “crazy talking point.”

    What they’re saying: “On the issue of not being able to do randomized trials, what is the calculus here? Are we going to wait to use something that can save thousands of lives just so we can have a study that tells us what we already know?” Navarro told MSNBC.

    “The odds of this being able to hurt you are close to zero, so it’s safe. The odds of it being able to help you are close to 100%,” Navarro claimed.

    Reality check: The odds of plasma being able to help COVID-19 patients are not “close to 100%.

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  2. @Scott: Thanks for catching that and brining it to my attention.

    And Navarro is just the worst.

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  3. Kathy says:

    The irony is there are two drugs that help in COVID-19 treatment, remedesvir and a steroid whose name escapes me, and Trump hasn’t made a big deal about them (maybe he can’t pronounce remedesvir?)

    BTW, convalescent plasma has been used all over the world for months. The effectiveness is unclear. The idea is the plasma contains antibodies to SARS-CoV-2, and these will prevent millions of viral particles from entering healthy cells. This kind of treatment ha been used in other viral diseases.

    The main limitation is that the number of antibodies in a unit of plasma are limited, and they don’t produce more antibodies in the patient’s body. They can’t Antibodies are proteins made by B-Cells in the immune system. A solution is to develop other means of making antibodies in quantity. I posted a few days ago about using horses to breed antibodies, much like antibodies for snake venom are made*. there are also pharmaceutical companies attempting to make them.

    *Antibodies for venom work better, because venom is not bio-active. The amount of venom you get when you’re bitten is all the venom you’ll have to deal with (that’s also why first aid for a snake bite includes drawing out as much of it as possible). Whereas viruses reproduce very quickly.

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  4. CSK says:

    @Scott:
    Among members of Cult45, Navarro is one of the most highly regarded of Trump’s advisors.

    1
  5. Gustopher says:

    White House economic adviser Peter Navarro said on Tuesday that recommendations from health experts that convalescent plasma undergo a randomized trial as a COVID-19 treatment before receiving an emergency authorization are a “crazy talking point.”

    His is literally opposed to science.

    I wish he would stick to talking about things he knows about. Like cufflinks or whatever, as we know it isn’t economics either.

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  6. MarkedMan says:

    @Scott: One of the things I have had trouble wrapping my head around is that these people, these Republicans, may not just be cynical people willing to say and do anything for their own short term gain, but may actually be as stupid as they sound. But in 2016 I saw just how many Republican House Members and even Senators seemed to have really believed the Republican Leadership really did have a fantastic Obamacare replacement ready to go, one that would cover more people at a cheaper cost. Now, I’m not saying they aren’t sleazy narcissists, just that they are also dumb as a box of rocks.

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  7. Gustopher says:

    @Kathy:

    A solution is to develop other means of making antibodies in quantity.

    I believe that our pandemic response plan might end up producing antibodies in quantity. And, if vaccines do not pan out, the US might become a great exporter of covid antibodies to all the areas of the world that have not let the virus run free.

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  8. MarkedMan says:

    Are we going to wait to use something that can save thousands of lives just so we can have a study that tells us what we already know?

    It’s depressing that most reporters don’t understand enough about this to have an adequate response. The answer should be “Of course not. If we know something is going to save thousands of more lives than it loses then we would go right ahead. But that’s not where we are at. Most treatments fail, whether due to side effects or lack of efficacy or actual harm. Controlled trials get us to “knowing” the fastest way possible. The treatments might help some people but they might also hurt some people, maybe a lot more than it helps. And specific dosing is important. L-Dopa was a truly miracluous drug for some people (for some time, but that’s a different story) but only when the amount was exactly and precisely correct. Maybe they help brunettes and blondes but kill 10% of all redheads. A controlled trial would get us to “don’t give this to redheads” as fast as we can get there, whereas once a drug is out and used in the general population there would many thousands of dead redheads before we knew, and we might never know. As it is, we are already doing away with things that we would like to test but we lack the time. For instance, there is no way these vaccines and treatments are going to be tested on pregnant women and their children observed for developmental issues before being approved.

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  9. Monala says:

    Dr. Sanjay Gupta breaks down the issues with the claims about convalescent plasma for C19, and why peer-reviewed, random controlled trials are needed:

    Dr. Sanjay Gupta
    @drsanjaygupta
    ·
    4h
    But, that doesn’t mean what Dr. Hahn originally said: that 35 more people — out of 100 — would survive. What that actually means is that 13.7/100 people died using low level antibody plasma, and that 8.9/100 died using the high level antibody plasma. (6/11)
    Dr. Sanjay Gupta
    @drsanjaygupta
    ·
    4h
    So in the high antibody group, 4.8 more people survived out of 100, as compared to the low antibody group. (7/11)
    Dr. Sanjay Gupta
    @drsanjaygupta
    ·
    4h
    But, there is another critical point. This was not a randomized controlled trial, the gold standard for clinical trials. Neither group was compared to a placebo, so we still don’t know if the convalescent serum itself offered survival benefit or not. (8/11)
    Dr. Sanjay Gupta
    @drsanjaygupta
    ·
    4h
    In fact, a closer examination of the study showed 49.8% of the participants were also being treated with steroids, 30.1% were treated with Remdesivir. So, was it the other medications offering the benefit or the convalescent plasma? We can’t say for sure. (9/11)
    Dr. Sanjay Gupta
    @drsanjaygupta
    ·
    4h
    The study, upon which this EUA was based, hasn’t been peer reviewed or published in a journal. (10/11)
    https://medrxiv.org/content/10.1101/2020.08.12

    I can’t find it now, but in the last week or so, I saw another Twitter thread by a researcher who pointed out that there can be side-effects to convalescent plasma, so even apart from the question of benefits, giving it to C19 patients is not risk-free.

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  10. Mikey says:

    This is why even though I am as far from anti-vaxxer as it’s possible to be, I will be extremely wary of any vaccine that comes out under this administration. Trump will do all he can to push any vaccine he can before Election Day, even if it is ineffective. Even if it has a high incidence of bad side effects. Even if it actually kills people.

    At some level in the stinking muck of ego and pig shit that passes for his mind, even he knows he has completely fucked up the response to COVID-19 and he needs every bit of the “miracle” he thinks is coming to stem the pandemic, because this isn’t like all his other failures–he can’t lie or blame-throw his way out of it this time.

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  11. Mikey says:

    @Scott:

    “On the issue of not being able to do randomized trials, what is the calculus here? Are we going to wait to use something that can save thousands of lives just so we can have a study that tells us what we already know?” Navarro told MSNBC.

    https://en.wikipedia.org/wiki/Thalidomide#Birth_defect_crisis

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  12. Scott F. says:

    As is usually the case, the problem derives from Trump’s epic narcissism. Prefaced with “I am not a clinician,” as I understand it, emergency authorization from the FDA can come via the science and it isn’t necessarily a problem when it does. Typically, when available data demonstrates the treatment is safe to use, then authorization can come when efficacy data is less robust. (Less common is the inverse – when efficacy data is really strong and the need is dire, desperate patients will petition to use a treatment that may not be proven as safe as possible.)

    Convalescent plasma has a history of safe use, so the random testing still needed would go toward demonstrating effectiveness against COVID. If Trump’s ego would have allowed the storyline to be “the risk is small enough it is worth trying,” then the FDA’s authorization would not be troublesome. But, Trump desperately needs “a historic breakthrough” that promises to reduce COVID deaths by a third. Respectable science becomes magic elixir!

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  13. DrDaveT says:

    @MarkedMan:

    But in 2016 I saw just how many Republican House Members and even Senators seemed to have really believed the Republican Leadership really did have a fantastic Obamacare replacement ready to go

    I’m surprised not to have seen these ads yet — they write themselves.
    “Remember what Donald Trump promised you last time he wanted your vote?”
    [video clip]
    “Remember what actually turned out to be the case?”
    [multiple clips of perplexed Congresspersons, ending with the infamous “Who knew healthcare could be so hard?” clip]
    “And in the years since… How gullible does he think you are?”

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  14. Kathy says:

    @MarkedMan:
    @Scott F.:

    All that, plus the peculiar way in which viruses reproduce.

    Viruses don’t have metabolic activity. They don’t eat and don’t reproduce on their own. they invade cells, and take over the cell machinery to make copies of themselves, killing the cell in the process. Antiviral medications interfere with this process, but don’t halt it altogether. And they don’t kill any live viruses in the body. This is contrary to how antibiotics work, by killing bacteria that do eat and reproduce on their own.

    These drugs and other treatments, like convalescent plasma, help keep the virus numbers down, allowing the immune system to better deal with them.

    So they help, a lot. but they are not a cure. There are no cures for viral diseases. none. We’ve been treating AIDS for decades, and we can’t cure it. We can keep it in check, so those afflicted can live normal lives, taking medication every day of them.

    Same with the flu. There are antivirals that work on several variants of the flu viruses, like Tamiflu. They proved invaluable during the H1N1 pandemic, and still thousands died, even some who were treated.

    The best hope is a vaccine. Until we have one, the best chance of not dying of COVID-19 is to avoid being infected with the SARS-CoV-2 virus. That means wearing a mask, washing your hands, keeping social distance, avoid gatherings of people, etc.

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  15. Gavin says:

    @MarkedMan:

    Republican House Members and even Senators seemed to have really believed the Republican Leadership really did have a fantastic Obamacare replacement ready to go

    Do you have one shred of evidence for the statement that any member of the party believed something tangible existed?
    I get that the talking points were consistent amongst Team R.. but talking points don’t rule out the possibility that they knew the words were fact-free as they were saying them. Your interpretation of strong belief could just be the True Believers who [idiotically] actually think they can speak something into existence if they say Beetlejuice enough times.

  16. MarkedMan says:

    @Monala: There are reasons that if someone is going in for surgery that might result in serious blood loss they bank their own blood beforehand, and some of those reasons involve the risk of disease transmission.

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  17. Kingdaddy says:

    I may need to ask my alma mater, UC Irvine, why Peter Navarro is still on the faculty, if he’s opposed to science.

    https://merage.uci.edu/research-faculty/faculty-directory/Peter-Navarro.html

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  18. Scott F. says:

    @Kathy:

    The best hope is a vaccine. Until we have one, the best chance of not dying of COVID-19 is to avoid being infected with the SARS-CoV-2 virus. That means wearing a mask, washing your hands, keeping social distance, avoid gatherings of people, etc.

    Which brings us back to Trump’s narcissism.

    The Trumpkins believed Dear Leader when he said COVID-19 wasn’t a big threat, so they don’t/can’t/won’t believe now that it is a threat big enough to change their behaviors. Trump’s ego means he will NEVER admit he has been wrong about the threat all along, so getting broader adoption of “best chance” behaviors from Trump believers is likely impossible unless they are faced with enough direct evidence to get them to believe their lying eyes over their POTUS.

    3
  19. MarkedMan says:

    @Gavin:

    Do you have one shred of evidence for the statement that any member of the party believed something tangible existed?

    Not any evidence that such a belief was wide spread, but some anecdotal evidence that at least some members believed their own BS. When Trump was elected and both houses of Congress were in Republican hands they immediately moved to repeal and replace Obamacare. A good number of members were talking about this nationally and in their own districts, which really puzzled me, because that’s not how I was expecting the Republican con to work. “Repeal and Replace was for when they were out of power. The obvious pivot was to “Repeal” and promise “Replace” down the road and it would never happen. But in at least two cases (and I think maybe three) there were scenes from town halls these Republicans held during a recess were enraged people were raking them over the coals and the Congress critters kept on pathetically insisting that, no, the Republican leadership did have a plan and it was ready to be voted on and it was so MUCH better than what they had now. But they looked puzzled and knocked off balance and so were either the worst con artists ever, or were so stupid they couldn’t figure out even the most obvious bull from their own party.

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  20. Nightcrawler says:

    @MarkedMan:

    Maybe they help brunettes and blondes but kill 10% of all redheads.

    Unfortunately, the GOP answer to that would be, “90% survival rate!”

    If these lunatics were in charge a few decades ago, we’d still be giving pregnant women thalidomide, because the chance of birth defects was “only” 20%, and most of those kids lived, so NBD.

  21. @Kingdaddy: Ugh. I was unaware of that.

  22. Gavin says:

    @MarkedMan:
    I’m also frustrated at the general lack of willingness/ability in the population to speak truth to power. Call it “an informed electorate” or something.
    When the angry constituent asked “What, specifically, are the components of this plan that’s going to replace ACA” and the congresscritter had zero precision.. the constituent should fire back “Thank you for admitting you have no plan and have been lying to us for the last hour.” This is the appropriate reply REGARDLESS of vague promises made.

    I get that dumb congresscritters can believe their own BS. That’s kind of a different idea though.

    My hypothesis [probably unclear] is that no R congresscritter actually believed they had a serious implementable plan. They may very well have [accurately] thought they could get another term by handwaving vague promises of things they might do in the future.. but that’s an election battle tactic not a strategic solution to a long-term systemic problem.

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  23. Just nutha ignint cracker says:

    @MarkedMan: Wait… isn’t the point of the “big lie” technique to get other people to believe that it’s true while you, yourself know that it’s not?

    Or am I the one who has that backwards? It’s sooo confusing.

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  24. Kathy says:

    @Just nutha ignint cracker:

    “It’s not a lie if you believe it,” George Costanza.

  25. Just nutha ignint cracker says:

    @DrDaveT: Why should they listen to you? You’re just another fake news, lying liar who is only saying that to destroy Trump because you know how right he is and hate him for it.

    Want to win? Get Democrats to go to the polls. The number of actual fence sitters can probably be counted on only one of Donald J. Trump’s incredibly small hands with fingers left over.

    @Kathy: Good point!

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  26. Teve says:

    @MarkedMan:

    my head around is that these people, these Republicans, may not just be cynical people willing to say and do anything for their own short term gain, but may actually be as stupid as they sound. But in 2016 I saw just how many Republican House Members and even Senators seemed to have really believed the Republican Leadership really did have a fantastic Obamacare replacement ready to go, one that would cover more people at a cheaper cost. Now, I’m not saying they aren’t sleazy narcissists, just that they are also dumb as a box of rocks.

    have you met James Inhofe? He found snow outside Washington DC one day during winter and threw it on the Senate floor, utterly destroying over 100 years of Physical, Chemical, and Geological research in a single heroic act.

    Inspired by a relative who was simply ineducable, I tried a few years ago a thought experiment, what would I think about lightning if I didn’t know anything about electricity. What would I think about hurricanes if I didn’t know anything about fluid motion? what would I think about plate tectonics if I didn’t know the basic features of the geology of earth? What would I think about vaccines if I knew absolutely nothing about immunology and viruses? Also, what if you never been taught to think? What have you never been taught that you can have an idea and you believe it’s right, but it’s wrong? What if you’ve never learned that you can’t just keep being right by keep arguing? What if you never learned that believing in something because you like the consequence isn’t a good way to think? What if you couldn’t understand that one guy with some letters after his name hawking weird products isn’t just as good as the medical community? What if you didn’t know enough to even see the product is weird?And I realized I wouldn’t have the ability to discern frauds and snake oil salesman, which this guy couldn’t.

    (Before somebody says we just don’t teach critical thinking these days, this guy was born over 70 years ago.)

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  27. steve says:

    The way Hahn presented the data was awful and unforgivable. The FDA is clearly working for Trump now, not for us.

    Convalescent history ha been used for a long time and is pretty safe. We have been using it in our network. Have not seen a big effect. If it has an effect we will probably need a real study to figure that out. Link goes to nice Derek Lowe piece about this. One of the reasons we are not further along is that everyone has just grabbed on to every treatment with little organization so we cant be sure what really worked. A lot of time wasted because Trump keeps politicizing stuff. Doctors really do want to find what works. It sucks watching these people die. It sucks talking with family who cant be with their loved ones as they die. It sucks spending all day wearing PPE. It sucks having an exposure and not being able to see your family for two weeks hoping you dont turn positive. It sucks if you catch Covid, recover, then are still wiped out for weeks. It sucks if you pass it on to family. It sucks if you catch it and die. There should be a special place in He*l for the fuc*ing A-holes who think we dont want to find a cure.

    Steve

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  28. steve says:
  29. Monala says:

    @steve: Sending good thoughts your way.

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  30. Teve says:

    @MarkedMan: Tom Cruise looks great and can emote on cue. Then you find out he’s a raging moron lunatic and you’re like oh yeah I forgot, he’s not paid to be smart.

    Many politicians are the same way.