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| Dance of death with plague victims, 1493 woodcut |
There’s not much treatment news in the last couple of weeks:
- Yet another negative study of convalescent plasma, this one coming from India, yet again flawed by poor donor selection – and yet more details of Trump’s in-person pressure on regulatory agencies to approve plasma therapy.
- Ruminations on using highly toxic ultraviolet light to purify indoor spaces.
- Speculation that since the ubiquitous disinfectant povidone-iodine can kill the novel coronavirus in test tubes, painting your nostrils with it might block COVID-19 from developing. Shades of old Trumpian fantasies, and totally untested. Shall we hold our excitement until the stuff has been tried in at least one actual human nose?
But vaccine news has provided more than enough excitement to compensate. I suggest you consider orienting yourself to the issues by checking out the superb and authoritative take of one top vaccine expert, Dr. Paul Offit. If you can’t access that discussion at Medscape (sometimes nonphysicians can’t), there’s a less deep one for the general public at WedMD.
AstraZeneca: The biggest clamor was around the Oxford vaccine having to suspend its Phase 3 trial because of a potentially devastating neurological complication, transverse myelitis, in a British woman who had received it. This is a very big deal. Transverse myelitis, which can cause paraplegia, is an autoimmune phenomenon that can be part of multiple sclerosis but can also occur in reaction to an infection – or a vaccine.
AstraZeneca started up again after only a week’s pause, but is recruiting new volunteers only in the UK and Brazil. An independent British regulatory authority apparently decided the neurological event (the second among AstraZeneca volunteers) was unrelated to the vaccine. The company refuses to give any details, on privacy grounds that seem to me and others to be wrong-headed not to say contrived, depriving the public and the rest of the scientific community of information that could be either reassuring or damning. American authorities aren’t convinced either, so the trial is not being restarted in the United States, at least not yet, and with what we know I personally wouldn’t volunteer. Critics are suggesting that if one more neurological event occurs the vaccine should be scrapped permanently – even though the company has already taken in at least $2 billion from countries around the world as down payment on a billion promised doses.
The way La Repubblica described the suspension news was touching: “Halt to testing of the Italian-British medication.” In reality the only Italian aspect of the AstraZeneca vaccine is that one of its many production plants is in Italy! Italians aren’t big flag-wavers, but they do love to feature local connections – say, mentioning at the drop of a hat that the US may soon have its first Italian-American in the White House (Jill Biden’s father, Donald Carl Jacobs, would have been Giacoppa if the name hadn’t been Americanized on Ellis Island).
Pfizer: This company has finally said for the first time that they have in fact performed animal studies of their vaccine, claiming “high levels of neutralizing antibody in various animal species, and beneficial protective effects in a primate SARS-CoV-2 challenge model,” but they don’t hint at details, much less promise to publish full results. It has now at least pre-published Phase 1-2 studies in human beings of two candidate vaccines. Both stimulated the immune system into producing antibodies, though one did a lot better than the other. Unfortunately the superior version also caused severe reactions, so they’re going forward instead with the other one, currently known as BNT162b2. Not extremely encouraging.
Sputnik V: The Russians have now published the Phase 1-2 evidence that made them approve this vaccine, and it’s scanty at best. About 75 volunteers were involved but as far as I can figure from the paper in The Lancet only 40 of them – mostly healthy men under 30 – received the final two-jab course. They developed anti-COVID-19 antibodies at levels higher than moderately ill COVID-19 survivors but lower than those elicited by some other candidate vaccines. Even less encouraging.
Research protocols: Three of the chief contenders have now released the protocols describing exactly how their Phase 3 trials, the ones aiming to show real-world efficacy, are being run. Moderna and Pfizer did it first, which gets them some points for transparency, with AstraZeneca trailing after. The plans themselves are disappointing, though – and I’m not the only one who’s noticed their defects. The endpoint all three companies are going for is symptomatic COVID-19. For Pfizer and AstraZeneca this could mean nothing but a brief sore throat with a positive swab. Moderna is a bit better, requiring volunteers to have respiratory symptoms plus fever or other systemic symptoms if they are to count as a case. But what we want from a vaccine isn’t protection from getting a few days of cough and fever, what we want to know is whether it will make us less likely to wind up with heart or brain damage, or on a respirator, or dead. All three companies would also be ready to stop the trial after only a small number of people – as few as 32 in the case of Pfizer (very bad), 75 for AstraZeneca and Moderna (merely bad) – have gotten sick. Insisting the vaccines be shown to prevent severe disease and requiring a proper number of cases would cost more and take more time, but in my opinion it is essential. Doctors are going to be advising billions of healthy people to be injected with a brand-new medication. We need to have complete confidence that the vaccine will ward off serious COVID-19, that it’s not going to kill anyone, and that the process of testing and approval has not been rushed.
Black October
Activist filmmaker Michael Moore has called it again. He was one of the very few pundits to predict Donald Trump’s elevation to the White House in 2016, giving him major creds for political soothsaying, and back in June, in his podcast The Rumble, we listened to him forecast Trump’s October surprise. Here’s how it ran: on October 25th the President goes on national television, announces a COVID-19 vaccine has been perfected on his WarpSpeed watch, and has himself shot up on live TV, scoring his highest ratings ever. The syringe will of course contain nothing but salt water.
This brilliant strategy seems more and more probable, and given the appalling kowtowing that’s been displayed in recent weeks by Stephen Hahn, the head of the US Food and Drug Administration, the agency empowered to approve all medications, it looks like the Trump team might pull it off. The risk of premature approval is so great that the vaccine companies have felt compelled to issue a statement swearing they won’t rush the science in requesting authorization, and both Hahn and senior FDA officials have had to say they won’t rush the science in bestowing it. But if Trump does get to carry out his stunt, in addition to being medically risky – that’s never fazed him – the timing has to be perfect. He has to be sure the real vaccine won’t be injected into any real people until after the election, because a monkey wrench will immediately land in the works.
How so? A personal story: nowadays people who need to be vaccinated against typhoid fever usually just swallow a few benign capsules. But I’m old enough to have gotten the previous incarnation of the typhoid vaccine, a shot in the arm that laid me up in bed for 24 hours, staring up at the ceiling alongside my similarly indisposed ex.
Compared to current candidate COVID-19 vaccines, that typhoid jab was a stroll in the park. If you shoot human beings up with the made-in-America Moderna vaccine, at a dose comparable to the one that worked well in monkeys, most of them lose days of their life to fatigue, body pain, fever, and headache, especially after the second dose. Candidate vaccines PiCoVacc (from Sinovac) and ChAdOx1 (Oxford-AstraZeneca) pack just as much of a whallop, the China Biotec, Pfizer BNT162b2, and CanSino ones a little less. I can’t say for the Johnson & Johnson/Janssen vaccine, since it’s only just now starting its first human trials.
If 40% of Americans already say they wouldn’t get vaccinated, what’s going to happen when the early adaptors land flat on their backs for days with fever, muscle pain, and headache –worse than the mild flu symptoms that Trumpians expect from the coronavirus? Even I, an enthusiast for nearly every vaccine that’s come around (exception: human papillomavirus) might drag my heels. And if the first vaccine turns out to be less than perfect, how many people will step forward to try a second one?
We can just imagine how few would get vaccinated when, as one Midwestern colleague wrote on Medscape, his patients are already suspicious that “the vaccine will contain anything from substances designed to promote sterility, to nano chips that will be injected to later track & control us.”
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| Michael Moore |
A bright side for the Dark Continent
Consider the buffalo. The breeds that live in India and Southeast Asia are happy to work the fields, under a yoke. The African ones would rather run you through with their horns. Same thing with elephants – the small-eared Eastern kind help clear forests all over Asia, while the floppy-eared African variety can’t be tamed at all. Africa has impoverished soils, years-long droughts, unspeakable viruses from Lassa Fever to Ebola that make the leap periodically from animals to humans… Ten out of 10 of the world’s poorest countries, and 22 of the poorest 25, are in Africa. By whatever measure you use, the continent always seems to start out with two strikes against it…
…except when it comes to COVID-19. Developing countries in South America and Asia, notably Brazil and India, are doing miserably, running neck and neck with the USA in terms of daily new cases and deaths. Major African capitals can reach twice the population density of New York City, and everybody including me expected that when the coronavirus reached Africa it would hit the ground running and decimate all those shantytowns, which given the widespread lack of modern medical services on the continent would mean an authentic holocaust. In all of Kenya – not one of the poorer countries – there are only 259 ventilators; Italy had ten times as many per capita when it was first faced by COVID-19, and even those proved far too few.
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| An African shantytown |
Instead, miraculously, the pandemic has merely limped along in Africa. Except for relatively wealthy South Africa, the case numbers, and the death rates per million (well under 100) look more like the sterling figures of Finland (62 deaths per million) or even Japan (12) than like Italy (581) or the US (618). Some of the apparent advantage is doubtless due to undertesting and underreporting, and the disease is continuing to spread, but most experts agree that Africa has had surprisingly few cases and low mortality.
How come Africa is, for once, an exception to a world-wide disaster zone? Could its very poverty somehow give it an advantage?
The answer may actually be yes. This blog has mentioned the theory that vaccines against tuberculosis, polio, and measles/mumps/rubella can stimulate the “innate immunity” branch of the immune system in a nonspecific way, boosting resistance to the novel coronavirus. It now seems that repeated attacks of malaria, and chronic infections with diseases including HIV/AIDS, tuberculosis, syphilis, and schistosomiasis, as experienced by far too many Africans, may bring the same kind of hyperactivation of the immune system providing partial protection from other infections. I noticed one hint of this in my clinical medical practice, when I observed early on that patients who grew up in Subsaharan Africa commonly had what for Europeans would be an abnormally high amount of gamma globulin – a/k/a antibodies – in their blood. I eventually found out that this was a well-described phenomenon, and decided I could start start ignoring that particular finding without further workup if it was merely a sign of an immune system supercharged by multiple challenges from infectious agents. What a wonderful paradox, if it turns out that the constant exposure to devastating diseases has kept Africans from suffering the full brunt of the COVID-19 pandemic!
What is happening in Africa, though, as in the rest of the developing world, is devastation from the cultural and economic repercussions of the pandemic. According to the United Nations, the lockdowns are reversing decades of progress on poverty, healthcare and education, leaving the poorest and the most vulnerable even further behind.
And the dire economic straits of Western countries during the pandemic are in turn further draining the Third World of resources, as immigrants who collectively sent home $554 billion to their families last year find themselves unable to keep up those remittances. It has been estimated that this shortfall alone will cause between 40 and 60 million people in the developing world to fall into extreme poverty (defined as living on $1.90 per day or less).
Mask, No Mask
Long-time readers know I’ve never been big on masks. I still haven’t lost my suspicion that they lead to a false sense of security (as per the Rome busses jam-packed with masked riders), and recent research from Johns Hopkins tends to confirm my opinion that they are much less valuable than physical distancing for stopping disease spread. Now, though, I’m finding one argument in favor to be fairly persuasive. Two experts think that universal mask-wearing might not only decrease the rate of COVID-19 infection, but could increase the relative rate of asymptomatic or mildly symptomatic disease among people who do get exposed. Here’s their reasoning. They start with the hypothesis that clinical COVID-19 severity may partly depend on the size of the inoculum – the more viral particles get into your body, the sicker you’re likely to get. The evidence for this is good in animals, and suggestive in human beings. They go on to present evidence that universal mask-wearing might cut down both the amount of virus that emerges from a person who’s carrying the coronavirus and the percentage of that smaller amount that gets into the person who gets infected. Completing the syllogism, masking all around should make for milder disease. Plausible, though still to be demonstrated.
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| No Masks at the White House Department: Mike Pompeo coughing into the face of the chief of Israel’s Mossad |
Herds of misinformers
I’ve written many times about the terrible proposal that a country could reach herd immunity without a vaccine by allowing the novel coronavirus to burn its way through the population until so many people are immune, 60% or more, that the rest will be protected. Terrible not because it wouldn’t work – it would – but because it would cause unspeakable carnage. Now, though, there is the very real possibility that Donald Trump has already started to use the American people as guinea pigs for the herd immunity fantasy. Under the rosiest of assumptions (getting sick gives you long-lasting immunity, only 65% of the population needs to become immune, and only 2.5% of diagnosed cases will die – in the USA until now 2.9% have died), going for herd immunity would mean more than 5 million Americans dying of COVID-19 and many times more going through hell and/or surviving with severe consequences. What’s my evidence that this is the new favored White House approach?
1) Trump’s new favorite pandemic expert, radiologist Scott Atlas, promotes it.
2) Trump himself has said so, though he garbled “herd immunity” into “herd mentality.”
3) According to Rachel Maddow the omniscient – it's not easy to assess from public sources – the federal government has quietly stopped telling states with the highest rates of new cases that they should take steps, such as mandating masks and closing bars, that would decrease the rates of infection.
Now, how about already dropped hints that some places might be approaching herd immunity already? Let me start with the case of New York City, begging forgiveness for flogging a horse that’s only half dead and for getting a little wonkish in the process. The New York Times reported a month ago that 27% of coronavirus antibody tests done on New Yorkers had been positive. But that does not mean that 27% of New Yorkers have COVID-19 antibodies, because – as I’ve pointed out several times – tests are done on people who are particularly likely to have been exposed. We already know from better sources that about 7% of New Yorkers had COVID-19 antibodies in April, and eyeballing the curve of diagnosed cases in New York State we can estimate that the percentage will have risen to 10% by mid-August:
Can we make these various numbers jibe? We know the people being tested are self-selected by having good reason to think they were exposed or infected, and we can assume reasonably that by August a high proportion of the latter – let’s guess 50% – had gotten antibody tests. In New York City as a whole 15% had been tested, of whom 27% tested positive. Twenty-seven percent of 15% means 4% with known infections. Double that, to account for the 50% or so of high-risk individuals who have not yet been tested, and you get 8% – not far from the 10% I estimated using other means. If you look at the hardest-hit part of New York City, the Corona neighborhood in Queens, 23% of the populationhad been tested and fully half of them tested positive. Double that and you can estimate that 23% actually had antibodies against COVID-19 – high, but far from herd immunity levels.
Then there’s Sweden, which followed something vaguely like the herd immunity strategy without getting the country anywhere within range of success except in achieving per capita death tolls 6-10 times higher than its neighbors. Sweden’s pugnacious chief doc Anders Tegnell seemed for a long time to be placing his bets on herd immunity, which he now denies one day and re-espouses the next. Lately the Swedes have had very few cases and almost no deaths. Because they’ve attained herd immunity? Not a chance. Wild claims that 25% of Stockholm residents were infected in the spring have been roundly refuted by serological studies of blood samples. One found that a mere 3.8% of Swedescountrywide had antibodies to the novel coronavirus, while another found a 6.8% rate in hard-hit Stockholm in June. The real reason Sweden is doing well is because the Swedes have been sensible. The elderly have sheltered in place despite the lack of an obligatory lockdown, whoever can works from home despite not being ordered to, indoor socializing is minimal, people follow WHO advice to keep their distance. And the other reason it’s doing well is that Sweden did eventually limit public gatherings, ban visitors from nursing homes, and start fining or even closing bars and restaurants where the customers were too crowded together.
Herd immunity will remain a mirage until we get a vaccine.
But, hey, herd immunity may actually have been reached in one place, the Brazilian city of Manaus. This spring a devastating COVID-19 epidemic was allowed to decimate the Manaus population without any mitigation measures worth speaking of, and cases have now faded away to nothing. I’ve looked into the numbers. Manaus has about 1.8 million inhabitants. The State it’s in, Amazonas, has double the population, but I’d guess Amazonas’s 127,000 known COVID cases were concentrated almost entirely in the city. Since the ratio of diagnosed to total infections is known to be about 1 to 10, that would suggest about 1.3 million Manaus inhabitants have been infected, 72% of the population. Maybe enough for herd immunity!
Who’s your pick for Most Outrageous? (Donald Trump disqualified for cheating)
On wearing masks: “It’s reminiscent of the 1930s in Germany, when people on their own bodies were tattooed.”
- Arizona state representative John Fillmore
On shelter-in-place measures: “Forcible imprisoning of people in their homes against all of their constitutional rights.”
- Elon Musk
On the Centers for Disease Control: “There are scientists who work for this government who do not want America to get well . . . these people are all going to hell.”
- Michael Caputo, saboteur-in-chief (now ex-) of the CDC’s Morbidity and Mortality Weekly Reports
On containment: “Stopping COVID-19 cases is not the appropriate goal.” On reopening schools: “Worst of all, social distancing rules...”
- Scott Atlas, radiologist, top advisor on the White House Coronavirus Task Force
On infrared thermometers: “They’re killing us . . . The health authorities don’t want us to know, because they’re all in cahoots with occult powers who want to sell us more medicines.”
- Dr. José Mena Abud, Mexican dentist
On how to overcome the pandemic: “The tractor will heal everyone.”
- Alexander Lukashenko, President of Belarus
The cause of the pandemic: “Same-sex marriage”
- Patriarch Filaret of the Ukraine, currently hospitalized with COVID-19
On treating COVID-19: “Bill Gates has had the cure since before the pandemic.”
- Patrizia Rametti, from Matteo Salvini’s League party
“Coronavirus is a cover-up for . . . child sex trafficking”
- QAnon-inspired email to BBC television
On face masks: “The exhaled viruses will not be able to escape and will concentrate in the nasal passages, enter the olfactory nerves and travel into the brain.”
- Russell Blaylock, MD, retired neurosurgeon, current snake oil hawker
On anti-COVID-19 measures in general: “Not unlike the divide-and-conquer dehumanization agendas that preceded the Holocaust”
- Kelly Brogan, “holistic psychiatrist”
On COVID-19: “You can’t catch what doesn’t exist”
- Skin Kerr beauty salon in England
On coronavirus disaster scenarios: “You know what, I’m ready. My daughters aren’t starving to death. I’ll eat my neighbours.”
- Alex Jones
An oldie but goodie: “5G radiation is greatly stimulating the coronavirus (COVID-19) pandemic and also the major cause of death”
- Martin L. Pall, PhD
On infrared thermometers: “Aiming a laser ray at our pineal gland for a virus that has a 99.9% survival rate”
- anonymous Australian nurse
On COVID-19 vaccines: “If you don’t mind aborted baby tissue, fetal tissue, to be injected into you, then go on and get the vaccine.”
Todd Bell, pastor of the Calvary Baptist Church in Sanford, Maine
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| A California church in August |
“This fake pandemic was designed to usher in the Evil New World Order and to enslave all people on Earth into a Communist Dictatorship”
- post on the Facebook page of an Australian politician
Concern about COVID-19: “Just another political stunt . . . There are the obituaries and funeral announcements that are simply not adding up to the actual amount of deaths.”
- Lisa Malakaua, Hawaiian activist and blogger
Why people get sick: “If God wants me to get Covid, I’ll get Covid.”
- Don Satterwhite, a Pentecostal minister in Oregon
The cause of the pandemic: “The Jews poisoned the wells.”
- OK, so the year was 1348, and the disease was the bubonic plague. Same difference.
