Treatment updates – good news!
Ferret it out: Here’s something I find really exciting. A prepublication coming out of Columbia University claims a nasal spray protected completely against COVID-19 . . . in 6 ferrets. The drug is a “dimeric lipopeptide” specifically designed to keep the novel coronavirus from binding to cells inside the nose – its usual way of penetrating into the body. Each test animal was housed together with a cagemate who had been infected with the virus. All the ferrets given a placebo spray, but none of those given a single daily spritz of active drug, caught the bug. A small caveat: the ferrets were treated before being exposed, so thus far we don’t know whether the treatment would prevent disease in, say, the spouse of a COVID-19 patient. It ought to be quick and easy to find out whether and how this drug works in people, since countless front-line health care workers and household members of swab-positive people would be appropriate research subjects. I can’t wait. This drug, which the researchers say is “inexpensive to produce, has a long shelf life, and does not require refrigeration,” could protect us during the long coming months before enough people get vaccinated for us to reach herd immunity. For the very first time since the pandemic began, I will go out on a limb and say this drug could be a game-changer.
Bamlanivimab (LY-CoV555): Eli Lilly’s monoclonal antibody preparation has now been given an emergency authorization by the US Food and Drug Administration to treat patients with mild-to-moderate COVID-19 who are at high risk of complications because of age or chronic disease. The FDA acted after the drug had been shown to reduce both viral load and symptoms in interim results from a placebo-controlled trial, plus a hint at decreasing hospitalizations. The trial is still ongoing, and hopefully final results on a larger patient sample will clear up some peculiarities in the published data, such as that lower doses seemed to work better than higher doses. Other issues include the limited supply of the drug and the logistics of getting it into patients – it requires an hourlong intravenous infusion, in the first days of illness. The United States has dibs on a good chunk of the anticipated production, so even though Lilly has manufacturing plants worldwide it may be months before much is available in Europe and elsewhere.
Inhaled nebulised interferon beta-1a (SNG001): I wrote back in March that inhaled interferon seemed like a good bet for advanced COVID-19. In fact it seems to be coming up roses, even for patients who are only moderately ill. Among 98 hospitalized patients randomized to inhaled SNG001 or placebo, those who received the drug were significantly more likely to improve, recovered faster, and may have been less likely to die than those on placebo.
Fluvoxamine: Some have suggested that this antidepressant in the SSRI family (Prozac, etc.) could treat COVID-19 by tamping down an exaggerated immune response. A trial in 152 patients with mild COVID-19, enrolled within a week of becoming ill, is encouraging: after two weeks of treatment, no subjects randomized to fluvoxamine, versus 6 randomized to placebo, had become short of breath with low oxygen saturation. I specify the numbers to emphasize how very small the study is. But any hint at an effect from a drug that is already well-known and comes in pill form is great. These tantalizing results require, and will surely spark, larger, more definitive trials.
REGN-COV2 (“Regeneron”): How come Donald Trump got treated with the antibody cocktail from Regeneron when Lilly’s seems to work better? And why would Patient Zero come out with what the New York Times called an “infomercial-style testimonial” for Regeneron? Could it possibly have anything to do with his being a golf buddy of the CEO? At least the Prez supposedly no longer owns any stock.
Remdesivir: Europe has tossed a billion euros into Gilead’s coffers to get its hands on 500,000 doses of the only drug so far licensed to treat COVID-19. But for now, it’s virtually unavailable in Italy and elsewhere in Europe despite the company’s promises to come up to speed in October, largely because the United States snapped up the entire supply through the end of September and beyond, also because Gilead is balking at licensing generic equivalents.
Tocilizumab: This and other drugs against “cytokine storm” have not been panning out, and the whole concept has now been brought into question with regard to COVID-19.
Vaccines – good news!
Pfizer: The big news of the week is of course Pfizer-BioN-Tech’s announcement that its vaccine is 90% protective against COVID-19 and will be submitted to the FDA for emergency authorization within weeks – the first Phase 3 results from any vaccine. But my enthusiasm is muted for what the Pfizer CEO has called “The most significant medical advance in the last 100 years.” Hype doesn’t make right. What excites me most isn’t the Pfizer vaccine per se, but the demonstration that immune system activation against COVID-19, which has been achieved by a number of candidate vaccines, can protect human beings from disease.
How come I’m skeptical? First of all, I (and others, and others, and others, and others, and others) am automatically suspicious of important scientific results trumpeted by press release before data have been published, prepublished, or even properly described. Second, the “COVID-19” Pfizer says its vaccine prevented is defined in their protocol as any symptoms, down to and including a two-day sore throat, accompanied by a positive swab. What we really want to know, though, is will the vaccine make us less likely to wind up with heart or brain damage, on a respirator, or dead. Pfizer isn’t saying. Third, we can’t say yet that the vaccine is safe – it will be another couple of weeks before even half the volunteers will have had the 2 months of follow-up considered the minimum necessary to exclude major side effects. Fourth, the company says a large percentage of its volunteers were “racially and ethnically diverse,” which is good, but not how many were elderly or chronically ill. If the vaccine works only, or mainly, in the young and healthy then it’s pretty useless. Fifth, we have no idea how long any protection will last. Sixth, we haven’t been told – though Pfizer undoubtedly knows – whether the vaccine prevents asymptomatic coronavirus infection, which has been key to spreading the pandemic.
My final caveat may be a little churlish: I tend to mistrust anything from the company whose (failed) rush to get results by Election Day was so blatantly pandering that top American scientists felt compelled to petition its CEO to hold his horses. Whereas now the indominable Mr. T. claims the results came in too late to boost his chances of reelection only because of the “medical deep state.” I love it.
Pfizer does get points for modifying its original research protocol, which would have allowed them to halt the study as soon as 32 subjects had developed COVID-19 – a scandalously low number. Instead, the FDA seems to have talked them into waiting until 94 cases had occurred before taking a first look at the data.
It looks like doses of the Pfizer vaccine will start rolling out, for American health care workers, toward the end of the year. Pfizer thinks it can manufacture 1.3 billion doses within 2021 – this sounds like a lot, but remember that you need two doses a head. 80% of those doses are already spoken for by the major industrial powers (US, Europe, Canada, Japan). In any case this vaccine is utterly unsuited to the developing world, because it has to be stored at -80º C (-112º F) – a requirement that creates distribution problems everywhere, since not even world-class hospitals have freezers that powerful.
CoronaVac: Sinovac’s Phase 3 vaccine trial, following in the footsteps of AstraZeneca and Johnson & Johnson, was briefly suspended because of an adverse event in a Brazilian volunteer. It turned out the adverse event was suicide, nobody blamed the vaccine, and the trial is back on track.
Moderna: The Phase 1-2 trial of Moderna’s vaccine has now been published in the New England Journal of Medicine, and confirms that mRNA-1273 successfully stimulates the immune system. There were only 45 subjects, all of them young and healthy, making the results underwhelming. But on November 11th Moderna announced that enough cases have occurred among its volunteers that they are ready to take a first peek at their Phase 3 results. They also specify that the trial subjects, at least those in the United States, are heavily weighed toward subjects whoc are elderly or chronically ill (42%), and/or minorities (37%). Eager to see those results.
Sputnik V: The Russians are saying they’ve got some data in from their Phase 3 vaccine trial and that – natch – it looks great, “92% effective” without any serious side effects. But a little rain fell on the party when the authorities had to admit that 4 doctors had caught COVID-19 despite being vaccinated. Plus the Phase 3 results sound less impressive when you find out they’re based on a mere 20 infected subjects.
Pricing: The leading companies are giving us an idea of the prices they propose for their vaccines: between “a few dollars” and “$37” a dose. Joe Biden has promised the federal government will cover those charges for all Americans, though a Supreme Court decision smashing Obamacare could throw a spanner in the works.
Pandemic Bulletin – Baaaaad News
In the meantime the coronavirus marches on, oblivious to advances on the pharmaceutical front. The world has passed 50 million cases and 1.3 million officially certified deaths. In the USA, where 250,000 have died, the National Geographic’s county-by-county map has never looked this red:
Early in October, when the official death toll from COVID-19 was about 214,000 in the USA, the CDC calculated that 299,000 more Americans had died during the pandemic period than in the same period of previous years, a 50% greater number. So in reality the pandemic has already caused two million deaths worldwide, close to 400,000 in the United States…
…and 64,000 in Italy, where the latest wave is even worse than in the US if you adjust for population. On November 12th 636 people died here of COVID-19, the equivalent of about 3500 in the United States (where “only” 1470 actually died). Hospitals in Rome are overwhelmed. Doctors who call the equivalent of 911 are being told to leave patients at home unless they’s at death’s door – anyone who’s not ICU material will remain alone on a stretcher in the Emergency Room for up to 72 hours waiting for a bed. Manual contact tracing capacities are stretched to the limit, and the Immuni app that was supposed to help out doesn’t. Every day I hear from at least one friend or patient who’s sick, tested positive, or exposed. I am personally damned scared, but apparently the general population isn’t. Romans wear their masks dutifully but flock to restaurants at lunchtime (they’re closed in the evening), where they eat one arm’s length from their neighbors, and – apparently – can’t resist having their friends over at night. Prime Minister Conte, who handled the pandemic like a pro this spring, watched the second wave swell for a month before instituting any new COVID-19 decrees. Now those half-baked measures are failing miserably, six Regions are already in lockdown, and the rest are on their way.
Italian Regions seem to be fudging their numbers so they can remain in the “yellow” zone, the one with the least restrictions. But they don’t hold a candle to the city of Madrid, which has improved its official case count by swapping out PCR tests in favor of antigen tests, which detect fewer than half of cases, to make the numbers look better. That sleight-of-hand can’t improve ICU occupancy or death rates, though.
So we’re all stuck with the same old same old. For people: keep a distance from anyone outside your household, avoid groups especially indoors, wear a mask appropriately, wash your hands. For authorities: test test test, trace contacts, and order scientifically-based mitigation measures.
One of many reasons to rejoice at the election of Joe Biden to the American presidency is that the see-no-evil hear-no-evil crap that has been trickling down since February has an expiration date of January 20th. The President-Elect is already doing all he can, I think: form a coronavirus Task Force that can hit the ground running on Inauguration Day, take every opportunity to urge the American public to follow healthy behaviors, and encourage governors to protect their populations by following the science.
But I am starting to fear that the influence of Mr. Trump and his enablers has created an atmosphere of ignorance and confusion that will be extremely hard to dispel even long after the man has stopped occupying the White House, the television screens, and our minds.
COVID cons: the latest on the fraud front
- Use only red colored soap or liquid to wash hands
- Corona-Cure Coronavirus Infection Prevention Nasal Spray (no ferrets involved)
- 5G BioShield USB Key (a $5 flashdrive sold at $230 as protective against the 5G-antenna emanations said to promote COVID-19)
- A "Virus Shut Out Protection" pendant to sling around your neck
- Influenza Complex homeopathic spray
- Abstaining from ice cream
- #NoMeat_NoCoronaVirus was trending for a while in India
- Inhaling nebulized hydrogen peroxide (Clorox redux – can lead to lung damage, strokes, and death)
- Datura (a deadly poison whose spiky fruit happens to look a bit like coronavirus)Touching the TV screen during an anti-covid sermon by Kenneth Copeland
- The BioCharger NG Subtle Energy Platform (a $15,000 light machine)
Conspiracy theories (here’s an interesting article focusing on the European varieties)
“Viruses will mutate, it will lose potency and we will recover without needing to shutdown.”
- Kyle Lamb, recently hired by Florida governor Ron DeSantis as a COVID-19 data analyst
Masks, social distancing, and handwashing: “They are not measures to control a virus, they are measures to control you.”
- Piers Corbyn (brother of Jeremy)
“There’s a once-in-a-lifetime opportunity to take this global cabal of Satan-worshipping pedophiles out, and I think we have the President to do it.”
- Marjorie Taylor Greene, newly-elected Congresswoman from Georgia
David Icke, best known for his theory that the world is run by a secret group of alien shape-shifting lizards, claims that Jewish cultists are responsible for the Covid-19 pandemic. A video to that effect was viewed 30 million times before it was purged from social media – or rather, as the Daily Stormer put it, before Icke was “shut down by the Jews.”
Leaflets being slipped through the doors of English villagers claim that face masks raise carbon dioxide levels in your blood and weaken your immune system.
Donald Trump invented, and his fans have picked up on, a vicious theory that doctors are padding the COVID-19 death count because they get paid more when that’s the diagnosis. The nugget of truth is that the CARES act allows Medicare to pay hospitals an extra 20% for COVID-19 patients. In reality, of course, the official COVID-19 death toll is known to be vastly underestimated.
QAnon, the quintessentially American conspiracy theory that encompasses COVID-19 denialism and Satan-worshipping pedophilic Democratic cannibals in a battle to the death with Donald Trump, now has nearly half a million followers across Europe, especially in Germany.
A new theory says that masks, gloves, and hand sanitizers actually increase your risk of getting infected by the novel coronavirus – but since promoters also say the virus is never fatal I don’t know why they care.
Other late entries:
- European elites invented and spread the coronavirus in order to kill off the elderly.
|Photoshopped still from The Simpsons|
- The Simpsons predicted the pandemic back in 1993.
- The second wave of COVID-19 in the United States is a hoax (one band of believers tried to sneak into a Utah hospital to prove it had empty beds).
- The Jews created and spread the novel coronavirus so they can control the world. A few posts back I referred jokingly to the “Jews poisoned the wells” theory of bubonic plague without realizing it had found new life as an internet meme.
One British poll found that 60% of adults believed the government was misleading the public about the cause of the virus. Another said 25% agreed with such statements as “The virus is a hoax” or “The elite have created the virus in order to establish a one-world government.”
A survey of 26,000 people in 25 countries has found that
- In Poland, Turkey, Egypt, and Saudi Arabia one in five people believed the coronavirus was a complete myth, fabricated by unidentified “powerful forces.”
- 60% of Nigerians, 38% of Americans, 28% of Germans, 13% of Japanese… think that the number of worldwide deaths from COVID-19 has been “deliberately and greatly exaggerated.”
- 37% of respondents in Turkey think the US government was responsible for creating and spreading the virus – and 17% of American citizens agree.
- Just for perspective, this poll also asked whether humans had made contact with aliens. In 17 countries, 20%-44% of people said yes.
How come all those people believe all that junk? Some scientists theorize that they’re suffering from something akin to frontotemporal dementia.
Thanks Susan. I appreciate the time and considerable effort this well written post must have take. I love the nasal spray stopping the zipping effect of the spike protein in particular. The vaccine trials are tricky. Might the numbers and time needed to show the effect of hospital admissions, complications and deaths be beyond possibility? This is why we still haven't proved that flu jabs reduce mortality, though in my experience in care homes, they certainly seemed to. I guess they argue if you don't get infected, then you wont get ill or die. The conspiracy theories would be hilarious if people actually didn't believe them. 44% of republicans, it seems, think Bill Gates want to use vaccines to microchip us all. Thanks again Susan, great read. I shall pass on some of this in my blog for family and friends if that OK.ReplyDelete
And, good heavens, pass on all you want - the more people read my stuff the happier I am.Delete
Dear Colleague, Thanks a lot, and I'm glad you share my enthusiasm for the nasal spray. Wouldn't it be great if they proved efficacy in weeks and had a billion doses on pharmacy shelves by Xmas? (fantasy, I know...) I had always thought the reason we hadn't proved flu jabs reduce mortality was that they didn't reduce mortality. But I see that I'm probably wrong and you're right - recent, better studies seem to give good evidence they reduce overall mortality and halve ICU admissions for flu. https://www.cdc.gov/flu/vaccines-work/vaccineeffect.htmReplyDelete
Info on remdesivir:ReplyDelete
As usual, you take us deeper into what we’ve seen in the news and ask the relevant questions we don’t know enough to ask. You are terrified about COVID in Italy, we are terrified the loser won’t leave.ReplyDelete
Thanks a lot. Believe me I too am acutely aware of the loser and his thugs, but I think Joe Biden is right to urge us to assume that everything will go smoothly in the end. He may go kicking and screaming but he will go. For a minute well spent, watch https://vimeo.com/221380805Delete