|Does this count?|
Remdesivir: Under the brand name of Veklury, remdesivir has become the first drug to get full approval from the US Food and Drug Administration for doctors to use in COVID-19 patients, though Gilead is struggling to make the supply meet the demand. FDA approval is probably good, because the drug modestly hasten recovery when administered early. True, the World Health Organization megatrial found it to be ineffective, but that trial’s validity is questionable given it started the drug so late in the course of disease. But beware of mistaking the modest benefits of remdesivir for “cure.” One expert commentator has rightly compared remdesivir for COVID-19 to AZT for AIDS – promising, but just the first step toward a final solution. Will there ever be a cocktail as effective against COVID-19 as HAART is against HIV?
Bamlanivimab: Eli Lilly has given up on testing its monoclonal antibody treatment in hospitalized COVID-19 patients, after an early peek at the data showed it wasn’t helping. (This trial was already on hold because of unspecified safety issues.) The flop is not entirely surprising. On theoretical grounds, because by the time a person is hospitalized he or she usually already has plenty of their own antibodies. And on practical grounds because we already had a pretty good idea the Lilly product, like the similar Regeneron one, works best when it’s given early. The problem is how to get an intravenous medication into patients within the first couple of days of illness, if they are not named Donald Trump.
REGN-COV2: Regeneron has announced further results of a placebo-controlled study among 799 outpatients with COVID-19, claiming success up and down the line. Unfortunately the endpoints it boasts of meeting look a bit weasely to me. Mainly, the drug did a great job at reducing the viral load in patients’ noses. The only clinical outcome they examined was whether the patients had any COVID-19-related medical contacts, including by telemedicine, during the month following their antibody infusion: 6.5% of placebo recipients vs. 2.8% of the drug group. These rates are ridiculously low, so the cases must have been very mild indeed. The press release gives no numbers for ER visits, hospitalizations, or even symptoms. One would have hoped for something more impressive. Plus there’s that same pesky need for intravenous administration… The place this drug had in COVID-19 treatment will, at least, have to wait for complete results to be made public.
Like Lilly, Regeneron has stopped testing its antibody drug in critically ill COVID-19 patients, but rather than saying it doesn’t work they’re citing an unnamed “potential safety signal.” Considering that one advantage of this drug class was supposed to be its lack of side effects, this phrase is a little ominous, especially since Lilly hinted at similar issues in halting its own study.
|Fleece-lined anti-COVID jackets woven from copper wire|
Heavy metal: For centuries elemental copper has been a folk remedy against infectious disease – not to speak of those bracelets that don’t work for arthritis. In COVID-19 days that old remedy has popped up again, including as virus-killing jackets. Dream on.
Active immunity: By now a couple of dozen people have been diagnosed with COVID-19 twice, with different strains of the virus. A mere drop in the bucket, among more than 43 million known cases worldwide, but a warning that neither infection nor vaccines will ever guarantee absolute protection. But here’s a little good news, for once! Buried inside an article about the umpteenth example of COVID-19 idiocy – a no-distancing sleepaway camp where one teen infected 115 fellow-campers and counselors – sits a very interesting fact: the only campers who did not get sick were the 24 who had tested positive for COVID-19 antibodies before arriving. For once a clearcut demonstration that having COVID-19 makes you immune. It would be nice if we knew just when those campers had been infected, to have an idea how long that immunity lasts.
Passive immunity: Italy is joining the monoclonal contenders, with a group directed by Rino Rappuoli for GlaxoSmithKline. They’re hoping to start human trials around Christmas of a triple-antibody concoction derived from the blood of recovered COVID-19 patients of Rome’s Spallanzani Hospital. Given that the results from the big guns in this category haven’t been brilliant thus far, and that by spring – the earliest time the GSK product could come out – there may well already be vaccines on the market, it’s not obvious how much added value GSK has to offer. A similar product from Astrazeneca is already into late-phase trials alongside those from Lilly and Regeneron.
Dream on Italian style: Some Rome physicians are plugging a milk protein as the ultimate answer to COVID-19. Under the heading of Italian Pride, this video’s titles read, “Dietary supplement blocks Covid-19: Italian discovery. Now what excuse will they find for vaccinating everybody?” The video dates back to July but is, like the virus, having a second wave, newly spiced up with the antivax banner. The supplement is called lactoferrin, and the doctor in the video is claiming it can both prevent and cure COVID-19. In reality, while lactoferrin may be an effective (very expensive) iron supplement for pregnant women, it’s never been shown to have any other benefits. It’s already sold locally like hotcakes, and Italian pharmacies have cleaned out. As P.T. Barnum is quoted as saying, there’s a sucker born every minute.
Raloxifene (Evista): The Spallanzani Hospital in Rome, Italy’s premier infectious disease center, is testing this osteoporosis drug in mildly ill COVID-19 outpatients. The researchers think its theoretical performance against virtual models of the novel coronavirus, and its known paucity of side effects, make it worthwhile trying in human beings. “Tentar non nuoce,” it never hurts to try. Fortunately the Italian group has chosen to run a proper, though small, controlled clinical trial instead of taking the easy way out, as has been done too often during the pandemic, of trying the drug without a placebo group.
Johnson & Johnson: Whew. The hold on the Phase 3 trial of my favorite vaccine only lasted a few days, before they decided the stroke suffered by one of their subjects had nothing to do with the vaccine. They’re back enrolling volunteers.
AstraZeneca: A 28-year-old Brazilian physician on the front lines died of COVID-19 after receiving a placebo injection in the Phase 3 trial of AZD1222. Tragic but fortunately not a reason to pause the trial. In fact the FDA has now given the company the go-ahead to restart enrolling volunteers in the United States, following a long pause to investigate a case of transverse myelitis.
The head of the line, or the back of the bus? People have been asking whether I will personally get a vaccine as soon as one is offered. My answer is that I’ve never been an early adopter of any therapies, and that this caution has always stood me and my patients in good stead. I did not, for example, leap on the 1990s bandwagon when “hormone replacement therapy” was being advocated for all women from menopause until death do us part. And I didn’t leap to the other extreme a few years later when menopausal hormones were being demonized. Time has proved my middle path right. For COVID-19, I’ll wait until not one but several vaccines have been approved, review all the scientific data, and see what trusted experts say, before deciding which if any to take myself and what to advise other people. I’ll keep you posted, of course. Bottom line: sooner or later, everybody should get vaccinated. The vaccines may not be perfect, especially the first ones, and may only mitigate symptoms rather than preventing infection altogether, but they’re the only way out of this mess.
First amendment follies,
Dr. Jon LaPook: During this pandemic, has the White House been controlling when you can speak with the media?
Dr. Anthony Fauci: You know, I think you'd have to be honest and say yes. I certainly have not been allowed to go on many, many, many shows that have asked for me.
(To get clearer on just why Trump has been muzzling Dr. Fauci, check out what Fauci told the Washington Post on October 30th. It may get him fired as soon as Trump no longer has to worry about the effect on his chances of reelection. Same for Deborah Birx.)
New waves, new fires
A mere 8 weeks ago I published a proud blog post on how well Italy was doing in the fight against COVID-19.
Pride goeth before a fall, and wow has there been a fall. Italy’s second wave started in late August, when reckless young folks brought the bug home from party-packed, discotheque-hopping vacations. A few weeks later they were passing it on to their parents and grandparents, and the second wave began in earnest – the age of new cases rose from 30 in August to 42 now… Despite how awful the curve looks, Italy’s second wave isn’t really worse than the first (at least not yet) – in the spring almost nobody was being tested.
Case numbers can’t be trusted as gauges of the pandemic because they are so dependent on testing rates. But COVID-19 admissions to Italian intensive care units can’t be argued away so easily. They rose slowly through September, then took off:
…only to be followed inexorably, a little later, by a vertiginous rise in the daily death toll. In recent days Italy is beating out the United States not only in the number of new cases but in COVID-19 deaths per day, in proportion to the population.
Under intense political pressure to keep the economy open, Prime Minister Conte pussy-footed around for weeks while Italy’s second wave swelled. Finally on October 25th he imposed a few anti-COVID-19 measures with teeth, and we expect a real lockdown any day. Most ordinary folk go along – only one in 4 think the new rules are too strict.. But cultural figures from movie director Nanni Moretti to conductor Riccardo Muti foolishly protested the closing of cultural venues, thousands of restauranteurs and shopkeepers demonstrated on the streets, and violence broke out on the streets of several cities. The latter weren’t signs of spontaneous social unrest, though. The smashed windows and the dumpsters in flames seem to have been the work of provocateurs orchestrated by organized crime (Mafia, Camorra) and neofascist groups.
Social Distancing, College Style
|The Rhythm and Brews bar, Tuscaloosa, September 26th, 2020|
“As a result of our combined efforts, the average number of daily cases, and the overall positivity rates in our community are declining. Although far from over, this positive trend provides an opportunity for a limited reopening of bars which have sacrificed a great deal to protect our healthcare system and economy.”
- Walt Maddox, Mayor of Tuscaloosa, Alabama, September 4th, 2020
By September 11th about 2000 students at the Tuscaloosa branch of the University of Alabama had tested positive for COVID-19 – up to 2700 now. There have been more than 200,000 cases among American college students and staff since the fall semester began.
Those outbreaks are not inevitable. Some colleges, and universities including Cornell and Duke, have held down casesto a bare minimum, by testing students multiple times a week, doing aggressive contact tracing, quarantining appropriately, monitoring dormitory waste water, closing local bars and frathouses, forbidding students to leave campus, and expelling anyone caught flouting physical distancing rules.
Foolish youth are everywhere, of course:
In Idaho, one of the farthest-flung, most rural, most conservative corners of the United States, COVID-19 is overwhelming hospitals. Some are having to ship patients 300 miles away, across state lines, for care. Republican officials are fighting back hard – to make things worse. One regional health department board voted to repeal an existing mask mandate, with a member commenting “Something's making these people sick, and I'm pretty sure that it's not coronavirus.” The board did restrict indoor gatherings to 50 people, but exempted churches, which in the US are prime superspreader locales.
Another man on that board said, “I personally do not care whether anybody wears a mask or not. If they want to be dumb enough to walk around and expose themselves and others, that's fine with me. Nobody's wearing the damned mask anyway... I'm sitting back and watching them catch it and die. Hopefully I'll live through it.”
Donald J. Trump’s latest contribution? “In California you have a special mask, you cannot under any circumstances take it off. You have to eat through the mask.” Incredibly, an Israeli has actually invented an eat-through mask (photo at top of post). Who knows, maybe California will yet make it obligatory.
The truth will out
“We have everything. Even without the vaccines, we're rounding the turn. It’s going to be over.”
- Donald J. Trump, October 25th, 2020
- White House Chief of Staff Mark Meadows, October 25th, 2020
The scales fell from my eyes…
For months this blog has featured mad COVID-19 gunners who claim masks make you catch it or thermometers will make your head explode. Now, though, for the first time I’ve looked down the barrel of the gun. It happened on Facebook. On October 24th I read an excellent article by Giorgio Parisi, an Italian physicist with unimpeachable scientific credentials, outlining how bad the local pandemic was, how much worse it was destined to get, and how urgent it was to take drastic countermeasures. The piece seemed uncontroversial and informative, so I innocently shared it with several expat groups.
Would that I hadn’t. The article drew responses that were an education for me on the reality of social media. Admittedly, they were mild compared to some twitter vitriol I’ve read about, and even to some of the comments I've had on this blog (March 7: “Your article is disgusting.” March 30: “I thought you could read Italian.” April 7: “Charitably, I might suppose that you were blinded by end stage TDS. If you were smarter…”) but still I found the latest comments impressive:
- “Propaganda!” (A CDC study showing that eating inside restaurants is risky.)
- A link to an interview with conspiracy theorist Mike Yeadon where he says, “The pandemic is fundamentally over . . . False positive results from inherently unreliable COVID tests are being used to manufacture a ‘second wave’ based on ‘new cases.’”
- “I know it [the coronavirus] is here and not going anywhere, it was here for many years already”
- “Don't impose your notions and scaremongering onto others and limit their inalienable rights and liberties.”
- A link to that video about lactoferrin.
- A link to German conspiracy theorists
- “Whoever believes what the WHO says any more??!!”
- “90% false positives [on PCR swabs] is also the figure mentioned by the top Italian virologist.” (I listened to the entire linked interview with Giorgio Palù, and he said nothing of the sort.)
- “There are also those who died of other causes, who happened to test positive for Covid, and then were counted as covid deaths.”
- “I listen to Nobel laureates top epidemiologists and virologists, but who are not government appointed advisors, and they are all agreed that the virus is not as dangerous as we are being led to believe by the media and some governments.”
- “Did you get it online… I bet you watch tv too, and listen to radio.....”
- About COVID-19 vaccines: “Congratulations. You will be among the first to eagerly pile into the railroad cars and transported to get the vaccine . . . You are so blinded by the propaganda, you drank the cool-aid without even asking one question of your controllers.”
- “You cannot control a virus and eventually everyone will get it.”
- About the October 23rd CDC report showing that not 210,000 but 300,000 Americans had died due to the pandemic: “The report is based on estimates and preliminary data. Still too early to assess the over-all impact in 2020.” I love the “still too early.”
- A link to an antivax Instagram post I felt obliged to call out as dangerously unscientific. The linker replied: “Obviously you are getting your information from the fake news media, google or manipulated Wikipedia.”
- “Humans create this virus”
- A link to an article that says, “Scientists, lawyers, medical professionals and academics are increasingly recognizing that the deliberate fear-mongering that has kept the COVID-19 pandemic alive threatens to replace democracy with fascist totalitarian models of government.”
- A link to an article that includes polio and measles when it says, “Every single vaccine is now being exposed for the lack of demonstrated evidence to actually prevent a single case of disease over a placebo.”
- A link to a French reposting of a viral American video whose original was purged from social media: “America's Frontline Doctors SCOTUS press conference.” AFD is a right-wing COVID-19-denier group that stars unlicensed ophthalmologists as well as the notorious Stella Immanuel, and their Supreme Court connection goes no farther than using the courthouse steps as backdrop.
- A link to a Donald J. Trump retweet about the Navy Seals who killed Bin Laden. (Confession: I’m lying. Nobody linked to it and it has nothing to do with COVID-19. But I can’t resist posting):
Expert advice, I have now discovered, says “Don’t debate on Facebook.” But boy is it hard to resist!