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Some thoughts on the president’s apparent recovery from COVID-19: “a Gift From G-d” that may help him lose the the election.

2020-10-08
photo courtesy of pixabay.com and Erika Wittlieb

According to this article in The New York Times on October 7, 2020, the president called his illness “A blessing from G-d”, supposedly because he discovered the effectiveness of Regeneron’s experimental monoclonal antibody treatment.

The article notes that the president appeared to be more heavily made up than usual, in a darker shade of orange, and that he seemed to be out of breath at times. This is subjective, but it seems to jibe with other information that has come out: namely, the suspicion that he has COVID-19 pneumonia and his apparent well-being is a result of side-effects from his steroid treatments.

Regeneron’s monoclonal antibody therapy development has been supported by a $500 million grant from the federal government as part of its “Operation Warp Speed” program. The antibody is expensive, difficult, and time-consuming to make. About 50,000 doses have been produced, with the capacity to have 300,000 doses by the end of the year. There have been some statements that suggest that the president was given an extra-large dose; 8 grams intravenously was mentioned, but it is unclear whether that represents a normal dose or not.

A single dose of antibodies would last about a month in the body. An antibody is a large protein, not filtered from the blood by the kidneys, and thus would continue to circulate for some time before it would be degraded. There have been suggestions that it would be useful prophylactically as well as for therapy.

To be clear, this treatment was given in a “compassionate use protocol” as it has not been cleared by the Food and Drug Administration (FDA) for general use. While the president claims he wants “everyone” to get it free of charge, there is not likely to be enough available to treat more than a small fraction of patients who would need it. Regeneron announced that they will request an emergency approval for general use. This will short-circuit Phase III trials now in progress since no-one will want to enroll in a trial where they might get a placebo instead of the real thing.

In addition to the monoclonal antibody, the president was given remdesivir in a standard dose as well as dexamethasone. The dose of dexamethasone was not mentioned, but normally six milligrams daily is given, which is considered a modest dose for this drug. The president’s upbeat mood, energy, and lack of fever has been ascribed to side effects of dexamethasone. How long this would be continued is unclear, although it was mentioned that this is the only drug he is still getting.

Some critics have claimed that the president has been behaving in a particularly erratic fashion since his release from hospital. For example, he stopped negotiations on a coronavirus relief package in Congress which one would think would have helped his re-election chances. The president is normally hypomanic all the time, and the steroids would make him even more manic.

Just today, the president refused to participate in the debate October 15 after it was announced that it would be held virtually. His handlers claim that a virtual debate would allow his opponent to use a teleprompter, a truly absurd accusation. It appears that the president’s real fear is that the moderators would find it easier to cut off his microphone when his opponent is speaking– since he used his open mic to talk over and interrupt his opponent repeatedly during the last debate.

In addition, the president may fear another debate after his drop in the polls following the first debate. Apparently many people were put off by his behavior, calling it bullying and disruptive.

Some misleading statements have appeared, as well as a lack of transparency about the president’s overall condition. For example, the results of his lung scans have not been given; some experts have suggested that the president has pneumonia (which would explain why he was given dexamethasone, which is usually reserved for people with severe disease who are on continuous oxygen supplementation.)

Another example of misleading information was the statement that the president has tested positive for antibodies to SARS-COV-2. It was pointed out that the positive test would most likely be a “false positive” given that he has just received a dose of exogenous antibodies. In fact, we wonder why one would even test for antibodies after having given them, unless they have some way of distinguishing exogenous from endogenous antibodies. For example, a test for IgM antibodies might be performed (the exogenous antibodies are all IgG.) This was not explained.

A final example of lack of transparency that has been brought up: no results of testing for the presence of the SARS-COV-2 virus after the treatment have been given. This test would determine whether he is still contagious to others and help us to determine how well he has responded to treatment. This particular information is especially important.

At last, we have the question of when was the last time the president tested negative for the virus. People who came to the debate last Tuesday were supposed to be tested, but the Republican contingent arrived too late and they were not evaluated. This glaring lack of testing should have halted the debate, but instead the Republicans came in and refused to wear masks during the proceedings.

The lack of information about the president’s virus test results makes his positive test on Thursday night, about 48 hours after the debate, extremely concerning. Was he already positive or during the window of contagiousness at the time of the debate? A lack of information, which the president’s doctors have failed to clear up, has us all concerned about the exposure of others at the debate– especially the president’s challenger in the upcoming elections.

Fortunately, Joe Biden has tested negative so far, but he is, like the rest of us, still not out of the woods.

4 Comments leave one →
  1. Eric permalink
    2020-10-08 3:18 PM

    This is a good summary of what has been in the news, but those of us who are not MDs would hope that you might shed light on whether you think he is truly stricken and will crash soon and have to be intubated, or whether you think he will actually walk away from this. We are unable to combine all of the above details in a cohesive way so as to make reasonable projections. I like to think that my projection, which is that he will crash within the next five days or so, is based mostly on the science that I am aware of and not just my unconscious or conscious hopes. But I am not at all sure. Perhaps as an experienced MD you can combine the facts that we think we know and the fog surrounding them (due to prevarication) and guess reasonably not whether he is faking it all (many think this), but simply whether this combination of medications can really save a man in his shape and presenting symptoms? I have seen some very detailed videos on what Covid does inside the body and I find it hard to believe that Regeneron or anything else will do more than postpone what is definitely coming for this man. But as already mentioned, I am not an MD. Thank you.

    Like

    • 2020-10-16 3:56 PM

      Sorry, but I didn’t see this comment when it was posted. (You can blame the fact that I get what seems like a hundred emails a day and the arcane architecture of this blog posting application.) It’s a little dated now, but I guess the virus is beatable with the right meds. Personally, I think the Regeneron and the dexamethasone and the remdesivir all together “saved” the president. I did learn that he received a very large dose of Regeneron, possibly eight times the “normal” dose– so it probably worked.

      Like

  2. Eric permalink
    2020-10-09 6:17 AM

    Maybe more revealing information in this article?? (New Republic) — No, Regeneron Did Not Cure Donald Trump of Covid-19
    And there was no excuse for that infomercial in front of the White House.
    On Wednesday afternoon, President Trump tweeted a nearly five-minute video in which he directly attributed his progress recovering from Covid-19 to a monoclonal antibodies treatment from Regeneron, a company in which he has previously invested. In the video, Trump implied that we no longer need to worry about the coronavirus because there is a “cure.”
    There are many reasons to object to the president of the United States advertising the efficacy of an experimental drug and promoting, by name, a company he has links to and whose executive is a member of his golf club, while standing in front of the White House. But there’s one in particular that doctors identified in this bizarre episode: The president’s own health updates cast a shadow of uncertainty on the treatment’s effectiveness.
    Earlier that day, Dr. Sean Conley, Trump’s doctor, released a letter that didn’t itself provide much new information. Trump, it said, was reportedly symptom-free for 24 hours. (That isn’t surprising if he’s still on medications like aspirin or steroids that suppress symptoms.) Trump hadn’t needed any supplemental oxygen since he was hospitalized, Conley wrote. He also wrote that Trump had detectable levels of what are known as IgG antibodies for the coronavirus.
    One detail that would indicate how well Trump is fighting the virus would be a decline in his viral load.
    More telling was what the letter didn’t say. One detail that would indicate how well Trump is fighting the virus would be a decline in his viral load, i.e., the amount of virus in his body. In preliminary results on the monoclonal antibody treatment REGN-COV2, announced by Regeneron in a press release last week, the medication seemed to lower the viral loads of patients with mild illness. If the treatment is working, Trump might expect to see such a decline. But that detail was noticeably absent from this and other updates on his health. In addition, Conley’s letter noted that Trump is showing levels of IgG antibodies—but he didn’t specify if those antibodies came from the Regeneron treatment itself, which usually lingers in the body for four weeks, or whether Trump is producing any of his own antibodies.
    With a history of cherry-picked updates on Trump’s health, experts say these omissions paint a startling picture. Based on previous updates, if Trump’s medical team were seeing any positive indications, they would have shared them. With that in mind, Trump’s pronouncement that he’s confident the REGN-COV2 is responsible for his miracle “cure” could be rather reckless. Not only is it experimental, he also has no actual evidence that it’s working—and he may have evidence that it’s not.
    “There is zero evidence that he is ‘cured,’ and even if he’s getting better, there is nothing to prove it was (or wasn’t) the Regeneron treatment,” Dr. Megan Ranney, an associate professor of emergency medicine and public health at Brown University, told me. “Moreover, claiming ‘miracle cures’ already got people in trouble with hydroxychloroquine and bleach; I wish the president had learned to wait before making these hyperbolic statements.”
    She said Conley’s mention of the president having IgG antibodies was “bizarre.” It implies that he doesn’t have IgM antibodies, a type of antibody the human immune system naturally produces before or at the same time as the IgG antibodies the treatment contains. Natural IgM and IgG antibodies would suggest that the body is mounting its own response to the virus, and they usually provide immunity for a few months. If Trump only has antibodies provided by the treatment, Ranney said, “then he likely does not have innate immunity, and when the Regeneron wears off, he will once again be susceptible to the virus.” To make matters more complicated, Trump is also taking dexamethasone, a powerful steroid that, when taken early in the course of Covid-19, could actually suppress the body from mounting its own immune response to the virus.
    “I wish the president had learned to wait before making these hyperbolic statements.”
    Ranney is taking Trump’s health updates with a hefty grain of salt. “I have to take these guesses because I can’t trust what is being told us,” she said. “All week long, the administration has provided incomplete or half-truthful press data about the president’s course. We are therefore forced to read between the lines.” Ranney said randomized controlled trials, not politicians’ statements, are the best way to know whether and how monoclonal antibody treatments work. “I do believe that this treatment is promising—it has good biologic plausibility for working—but it is just too early to say whether it is effective or not,” she said.
    Dr. Ellie Murray, an assistant professor of epidemiology at Boston University School of Public Health, also emphasized the importance of the gold-standard clinical trials. Yet Trump’s endorsement of his treatment could sway the perspectives of potential participants. “When people have already prior beliefs about a medication, it can mean that it can be really hard to enroll participants. And the Regeneron trial is still enrolling,” she told me. What’s more, because Trump is on several medications, it’s difficult to tell which ones have helped him, she said.
    Even if the clinical trials reveal that the treatment is effective, however, it’s not the panacea Trump promises in his video. Contrary to the astonishing production and distribution the president promised in his video, it would be very difficult, if not impossible, to produce enough monoclonal antibody treatments for everyone who is ill. Because of the limited supply, it will likely only be used among those who are at highest risk of the virus, such as health professionals and the elderly—and those who can afford it.
    Companies like Regeneron and Eli Lilly haven’t announced how much their monoclonal antibody treatments might cost, but the average annual price of existing monoclonal antibody treatments was nearly $100,000 in 2018. In his video, Trump claimed “everyone will get them free,” but it’s extremely unclear how that could happen—particularly for people who are uninsured or underinsured. In addition, because the treatment was developed by testing the antibodies against fetal tissue cells, there may be ideological opposition to it. (The treatment itself, however, does not contain cells from fetal tissue.)
    Perhaps most concerning, in a slew of disturbing news, is Trump’s continued efforts to overrule or politicize the normal regulatory process for new drugs and vaccines. Until recently, he has repeatedly promised a vaccine would be available by Election Day, even if the administration had to override regulations by the U.S. Food and Drug Administration. In his video Wednesday, the president said “I’ve authorized the EUA,” or emergency use authorization, to make the Regeneron treatment available to the public before the clinical trial data exists. Not only does that appear to be untrue, that’s also not Trump’s decision to make: The FDA authorizes EUAs.
    While treatments like monoclonal antibodies seem promising, every expert I’ve spoken with over the past 10 months of reporting on the coronavirus has emphasized that the Trump administration continues to undermine potential progress by recommending certain treatments, vaccines, tests, and pandemic policies without having sufficient data. Far from helping, such announcements could do lasting damage to efforts to develop accessible, affordable, effective ways to stop the virus.
    Melody Schreiber @m_scribe

    Like

    • 2020-10-09 9:50 AM

      I agree with the information presented in this comment. The only really useful information is missing— his viral load. I suspect that if that were promising, they would have presented it, but they have not. If it still shows virus then he is not cured. Monoclonal antibody is a very promising treatment but not proven. As a friend of mine used to say, “What can I say about this elixir?” Only time will tell.

      Like

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