Viewing Raphael at the Scuderie del Quirinale gallery in Rome
Remdesivir: The manufacturer’s announcement I described back in June, reporting peculiar results in patients hospitalized with moderate COVID-19, has now been published. Those randomized to get 10 days of therapy (they actually got an average of 6 days) did no better than controls, while those randomized to get 5 days (they actually got a similar average, 5 days) were marginally better off than controls on day 11, the benefit barely reaching statistical significance. These results were so weak that the researchers themselves felt obliged to describe their results as “of uncertain clinical importance.” Does this drug really deserve its lucrative superstar status?
Tocilizumab: This once-promising drug did no better than placebo, in a proper randomized trial, at bettering clinical status or mortality of severely ill COVID-19 patients at 28 days. The authors considered the trial a bust – but their drug cut the time to hospital discharge by a full week, better than what’s been reported for the above-mentioned remdesivir. Hmmm…
Icatibant: A hypothesis around for many months but highlighted lately claims that bradykinin, a molecule involved in inflammation, holds the key to COVID-19’s mysteries. Now a pilot study of the bradykinin blocker icatibant, very small and methodologically weak, has suggested it might conceivably help some severely ill COVID-19 patients.
Convalescent plasma: In my last post I called the Mayo Clinic study very promising. But, good God, it certainly didn’t suggest, much less prove, that convalescent plasma cures 35% of COVID-19 patients! The US Food and Drug Administration chief who made that outrageous claim did walk it back a smidge a couple of days later, but that’s nowhere near enough. We’re used to the FDA being unduly influenced by Big Pharma, but for the physician-scientist at its helm to tout outright lies to the public, presumably following the President’s wishes, is far far beyond the pale. Stephen Hahn should have resigned on the spot. How will we ever be able to trust in an FDA-approved vaccine?
Designer antibodies: Two companies with products in this convalescent plasma-like category, Eli Lilly and Regeneron, are having enormous trouble getting their treatment trials going in the United States because of . . . lags in testing!!! Italy, a country much poorer in cash and medical resources, is managing to test everybody arriving from high-risk countries, fast. I find it impossible to believe American hospitals can’t manage to even for a well-funded Big Pharma clinical trial.
Vaccines: Italy joined the race, in its small way, on August 24th, injecting a first volunteer with the Grad-COV2 candidate vaccine, hailed by the Italian press. To me it seems premature to inject human beings with a vaccine when all we know about it is that it stimulates the immune system in mice. As far as I can tell it has never been tried in monkeys, and even the vaccinated mice haven’t been challenged with coronavirus. Elsewhere, the Oxford/AstraZeneca vaccine, now called Covidshield, has become the first major contender to run a Phase 3 trial in India; the Russians are belately starting such trials of Sputnik V after approving it for clinical use. And now, in perhaps the worst possible COVID-19 news, Trump has joined Putin in the Cart Before Horse department, strong-arming Anthony Fauci into going along with possible pre-election approval of a half-baked vaccine, risking not just Americans’ faith in vaccines but also their lives.
Mouthwash: Put this one in the Department of Dream On.
Testing: The Centers for Disease Control have been bullied by the White House into quietly issuing a shocking guideline saying that people without symptoms don’t need to get swab testing, even if they’ve been exposed to COVID-19. This negates the very concept of contact tracing, the technique at the core of epidemic control, and means that safe reopening of colleges goes from unlikely to impossible. After the FDA, my trust in another agency crucial to our health bites the dust. In the meantime, a rapid antigen swab test suitable for use in doctors’ offices, the BinaxNOW Covid-19 Ag Card, has been given emergency authorization for American use by the FDA; the manufacturer, Abbott, claims it is much more accurate than its previous rapid swab test, which missed as many as half of COVID-19 cases. This cheap new test could be a game-changer.
Anticoagulation: COVID-19 is characterized by widespread blood clotting, so it makes sense to treat it with anticoagulants. But several small retrospective studies and autopsy series have failed to show much benefit. Now a larger retrospective study from Mt. Sinai in New York, my medical alma mater, compared hospitalized COVID-19 patients who did vs. didn’t receive heparin-type anticoagulants and found that the ones who did were less likely to die. The problem, as for the Detroit study of hydroxychloroquine I tore apart a few posts back, is that “standard care” probably improved over the course of the study, and by the end of the New York City epidemic doctors were prescribing anticoagulants across the board. So patients who received them were likelier to have been hospitalized late in the epidemic, when treatment was better all around. It’s impossible to verify, since the article doesn’t report the average dates of enrollment in the two patient groups.
Italy and the coronavirus: The Good
I wish that when we went into lockdown, we looked like Italy. When Italy locked down, I mean, people weren't allowed out of their houses. Americans don't react well to that kind of prohibition.
- Dr. Deborah Birx, Donald Trump’s Coronavirus Response Coordinator, August 17, 2020
Dear Dr. Birx,
You’re spot on about the Italian lockdown. But Italians don’t react well to “that kind of prohibition” either. On the contrary – they’re famous for sneaking past no-entry signs, smoking under no-smoking signs, barreling along at 80 in 35 mph zones, fastening their seat belts under their butts. The difference is that they’re no fools, they can tell what’s important from what isn’t, and once they understood that their lives depended on it they did the right thing.
- Susan Levenstein, MD, Rome, Italy
Much of Europe is having to fight off a second wave of COVID-19, with Belgium, France, Spain, and Germany all reinstating some restrictions. Eastern Europe is even worse. The notoriously anarchic Italians are amazing both Americans and themselves by remaining among the winners, with a swab positivity rate hovering around 2%; it’s 6% in the USA. As Roger Cohen wrote before coming down with COVID-19 himself, “Italy coheres and America breaks apart.”
How come Italy, famed for disorganization, disobedience, and discord, is doing so well? I sketched the reasons for France2 TV:
1) As Dr. Birx points out admiringly, Italy’s Phase 1 was one of the strictest and lengthiest lockdowns in Europe, with a truly astonishing level of compliance from its population, who for 12 weeks had to carry a pass every time they left home to certify they were out shopping for food or medications (masked and distanced), or walking for exercise. All within 200 yards of home; no driving except to the hospital.
Life under lockdown was made bearable by community and family cohesive spirit, the willingness of corner grocery stores to make deliveries, and the constant availability of products such as surgical face masks, disinfectants, and toilet paper – no T. P. Arias here.
2) The virtues of the Italian health care system, welfare state, and political system shone. Nobody pays for primary care visits, hospitalizations, or COVID-19 swabs, medications never cost more than a couple of bucks, most workers have 3-6 months paid sick leave, and despite some leeway for individual regions the central government has generally been able to dictate policy countrywide… A Facebook friend commented that one reason Italy has done well is “Because despite political differences Italian leaders actually care about their citizens.” Imagine!!! In short, Italy has revealed itself to be a civilized, unified country in a sense that the United States is not.
|Currently hospitalized COVID-19 cases: Italy|
|Currently hospitalized COVID-19 cases: USA|
3) Despite some grumbling, Italy has not seen the anti-mask, open-it-up madness that has trickled in the US from the White House on down.
4) Italy has been smart about reopening, with almost all regions resisting opening the bars, nightclubs, and discotheques that have contributed to the second wave in Spain and the ongoing disaster in the United States. Lombardy did make a stab at allowing discotheques in June – for outdoor dancing only – but when the authorities saw the crowds on night one they closed them back down.
5) Italy is long over the worst of its testing shortage. For months it’s had so few new cases and so many trained trackers that they can do real contact tracing, finding all the people who have spent 15 minutes within 6 feet of, or shared a closed space with, every person who’s tested positive, and quarantining them for 2 weeks.
6) The authorities are offering voluntary random spotchecks with free swab tests at locations such as Ikea parking lots, which have turned up many thousands of asymptomatic cases.
7) Traditional health mania may be contributing to Italians’ unexpected acceptance of the new normal: fearing pesticide residues on the peel, many won’t just pick up an apple and eat it, instead deftly wielding knife (and sometimes fork) to transform the flesh into neat naked quarters.
8) But, mainly, Italians have on the whole been careful.
Stores have no trouble enforcing the mask ordinance, and many add obligatory hand disinfection.
During patient visits we’re both masked, the window wide open, and the air con blowing. I wash even better than usual after each patient and disinfect anything they might have touched, from chair to stethoscope. It’s a drag, but it makes sense. The waiting room is well-ventilated and near-empty – no accompanying family or friends – and all items that risk repeated handling (including alas the copy of my own book) have been removed.
We’ve attended only one concert. It was not only outdoors, with assigned seats yards apart and masks whenever you stood up, but the organizers gathered names and phone numbers in case they needed to trace contacts.
We saw the marvelous Raphael exhibition at the Scuderie del Quirinale, twice. Masked groups of six were ushered between one room and the next every five minutes at the sound of a bell. I’d have appreciated another couple of minutes per room, but it all felt perfectly safe. Again, names and phone numbers all around.
One of the joys of emerging from quarantine was scoring an appointment with my hairdresser (he was strictly walkin in the past). Masks, distancing, judiciously worn gloves...
We haven’t eaten indoors in the presence of other people yet, but we’ve enjoyed several tiny social dinners in courtyards or on terraces. All my patients claim to follow the same strategy, though I admit they’re no random sample.
Italy and the coronavirus: The Bad
Italy may be avoiding a second wave, but it has had a ripple. New cases have crept up from 200 a day during July to 1200-1700 now. Recent cases are evenly divided among three groups: people tested because of symptoms, cases detected by tracing and testing the contacts of COVID-19 patients, and asymptomatic cases detected by random mass screening.
What went wrong?
Italy isn’t immune to the raves where young people have been blowing off steam in Europe. There was a rash of indoor bashes in northern Italy back in June. Now, with Carabinieri finding and fining many of the organizers, the ravers seem to at least be sticking to open fields, which are less coronavirus-friendly even without masks. In Rome some discotheques have tried opening on the sly, and gotten busted. The Rome police have even sealed off some of the most popular hangout piazzas – Bologna, Santa Maria in Trastevere, Trilussa.
Several regions, notably Tuscany and Sardinia where young vacationers are the backbone of the summer economy, defied the national shutdown of dance locales, and irresponsible youth (is there any other kind?) have fueled Italy’s modest second wave. Hundreds returning home from fancy Sardinian vacation spots have carried the virus all across Italy. In one locale, modestly named The Billionaire, half the staff including the jet-set owner have tested positive for COVID-19, and at least one wound up on a ventilator. Their clients all left coordinates for contact tracing, but lots of the names and cell numbers have turned out to be phony, reducing the health authorities to making public appeals for club-hoppers to get tested.
|The Billionaire, Flavio Briatore's Sardinian nightclub|
I have to say if there’s any circumstance the bug can be caught out of doors it’s the groups of 20-year-olds piled up on Italian beaches, making out en masse. And when is “outdoors” not outdoors? When it’s one of those vast Italian discotheques whose dance floor is only nominally outside.
A Lumbardy discotheque with “outdoor” dancing, reshuttered after one night
The disease is also being imported by Italians returning from foreign vacations, especially young nightclubbers, driving the average age of newly diagnosed cases down to 30. Italy now requires everybody returning from Spain, Greece, Croatia, or Malta to be swabbed for COVID-19 shortly before or after arriving. It’s gone surprisingly smoothly, with rapid testing centers set up in boat ports and airports – results within an hour – and a mushrooming of drive-by locations that email results in 24-48 hours.
|A drive-by swab center. The sign says "Don't get out of your car"|
Many of Italy’s newly diagnosed COVID-19 cases have been among foreigners. Some have Italian residency but slip in from high-risk countries, often aware that they have been exposed to the virus. Huge outbreaks have been documented in the Bangladeshi community, with well-publicized cases of swab-positive immigrants landing in Italy with fake no-COVID certificates or sneaking out of self-isolation to bum around on trains and busses, spreading the virus as they go. Rumanians, too, were sneaking over the border, by the nocturnal busload and in private cars. Italy responded by cancelling flights from Bangladesh, ordering returning Rumanians to quarantine, and performing mass testing in both communities. Other hotspots involved Nigerian farm workers and camps holding illegal migrants – hundreds of African “boat people” have, not unreasonably, fled from crowded detention centers when fellow-inmates started to test positive.
With the minisurge in cases, the number of COVID-19 patients in Italian ICUs has nearly tripled. The death rate lags, staying mostly in the single digits since the last week of July. And with ICU patients now much younger than in Italy’s dreadful first wave, and younger COVID-19 patients are more likely to survive an ICU stay, perhaps the death rate will stay low…
Degrees of nuts
American colleges opened complete with frat houses, karaoke bars, and bacchanals: 51,000 cases among students as of September 3rd, including 800+ at the University of Iowa and North Carolina State, 1300+ at the University of Alabama. San Quentin imported the disease more or less deliberately from another California prison: 2100 cases and 19 deaths. Over-the-top weddings and undistanced schools have handed Israel a second wave many times worse than the first and still ongoing.
Ultra-Orthodox wedding in Israel, August 2020
|Israel's first and second waves of COVID-19|
The frightening Australian second wave has apparently been fed by hotel staff who were extorting sex from recent arrivals in return for letting them sneak out in defiance of quarantine. Spain, despite having peaked at over 9000 new cases in one day and briefly rivaling the US in daily cases per capita, is still allowing indoor bars and nightclubs to stay open, at only slightly reduced capacity. Trump isn’t the only COVID-19 idiot around.
Italy has dodged those bullets, but people are definitely getting sloppier. Even when they obey the requisite 3 feet of physical distancing it seems paltry. I actually felt a momentary shock when friends sent a photograph of 10 of them sitting, “distanced,” at an indoor restaurant table.
Around Rome moderate prudence seems the norm. Lots of masks even out on the street, one customer at a time in small shops. Supermarkets aren’t overcrowded, no lines on the sidewalk, but there’s not much distancing once you get inside; people seem to think if you’re wearing a mask you can get as close as you want. Coffee bars vary, with some unfussy about masks or distancing, but the risk is relatively minor given the Italian way of coffee: drop in, knock one back, and head out the wide-open door within five minutes.
Outside the big city I gather things are different. Small-town spies tell me they see folks greeting each other with baci e abbracci – hugs and kisses – and visiting indoors cheek by jowl.
Official Italy is slipping too. The careful screening of incoming travellers seems to have gone by the boards. My husband and I, arriving on a flight from Paris but on a journey originating in the United States, were interrogated in detail and had to provide an address and telephone number for where we would spend our quarantine – the health authorities phoned to check on us every single day. Lately if you’re not coming from a high-risk location they just wave you through. (They’re doing a good job of ensuring people coming in from Spain etc. get tested, though they really ought to make them have a second swab a few days later.)
Public transport is supposed to run more frequently and to plaster “Do Not Sit Here” signs on half the seats, and private cars are being allowed into the closed center of Rome to ease the burden on busses. But the second time I took a tram I waited nearly 20 minutes, the car was packed, the windows were sealed shut, and all the Do Not Sit Here places were occupied. No more public vehicles for me… At least everyone was masked.
|Busses: the dream|
Polls say that if a vaccine against COVID-19 were available, 41% of Italians would probably not choose to get it. But that percentage is about the same in the United States – where one preacher in Maine has told his flocks that the new vaccines contain “aborted baby tissue” – and in Germany, another safe home for no-vaxxers.
Putting food on the table
The coronavirus pandemic has taken an enormous toll on an already frayed Italian economy, though the Financial Times and the New York Times think they’ve done pretty well at juggling money and lives. The economy had been creeping back after the 2009 crash, with official unemployment (considered an underestimate) finally dipping below 10% last year after a peak of 12.7%. Now it’s back only to 11%, but experts call this relative stability “an optical illusion.” The worst hit have been the young, concentrated in decimated industries such as tourism and hired on temporary contracts. Throughout the pandemic half of Italians fear their jobs are at risk, and half of the newly jobless are under 35.
Italy’s second quarter GDP is down 18% from last year, and at its lowest level since 1995. Pandemic aid packages have expanded Italy’s budget deficit to 12% of GDP and public debt to 162% of GDP – the EU fortunately responded by temporarily suspending its fiscal rules and providing cash support for the labor market.
Many ordinary folk have had €600 ($710) wired into their bank accounts a couple of times, a pittance, and only if they’ve been paying their taxes properly. The already desperate millions working under the table in the “black” economy are eligible for nothing at all. Government assistance has given some small businesses enough of a windfall to make up most of their lost income, and the strings attached requiring workers be kept on the books have avoided some layoffs. But, again, people working off the books or in the gig economy, and small-time independent contractors, are up shit creek. In June 45% of Italians said their income had dropped due to the pandemic and another 35% expected it would.
I ask every patient who comes into my office, and every friend, how they’ve been bearing up under the strain of the moment. Several have burst into tears. Early in the lockdown Italians kept going on shock and community spirit, but once the adrenalin ran down anxiety and depression took over. I’ve heard of 4 suicides.
I commented to one Italian friend who’s old enough to remember World War II that this was the first time since then that people had to tolerate such disruption of their lives. He agreed but added, wisely, “The pandemic is worse. During the war we still had our dreams.” Now people everywhere have lost all sense of the future, and their dreams along with it.
Italy and the coronavirus: The Ugly
Build The Wall
The ugliest is the neotrumpian antiimigrant frenzy being whipped up by the country’s right wing in the persons of frankly fascist Giorgia Meloni and merely racist Matteo Salvini. As I’ve said, many of the cases in the recent COVID-19 surgelet have been among foreigners. But by far most are Italian born, bred, and transmitted.
Open it up
Andrea Bocelli singing in Milan’s Cathedral
Marginally less ugly are the varieties of COVID-19 minimizers.
As Italian deaths fell mutterings about herd immunity arrived – is there less disease around because by now everybody’s immune? No! No! A thousand times no! In Milan, an epicenter of the Italian epidemic, mass antibody testing was done recently on bus drivers who had worked at its peak and would have been at extremely high risk. Only 7.7% were positive. A similar rate of coronavirus exposure was found in Milan blood donors in early April. In Rome’s Lazio region, in mid-June, the antibody positivity rate was only 2.4% among people who chose to be tested, the likeliest to be positive.
With less disease around, the sabotage to mitigation measures is heating up a little. A few professorial types blast the lockdown after the fact. The prominent publicity-hound physician Alberto Zangrillo continues to minimize, denying the threat of a resurgence even as his long-time patient Silvio Berlusconi is hospitalized for COVID-19 double pneumonia. It comes as no surprise that right-wing leaders such as the League’s Matteo Salvini are too macho to wear face masks, but I was saddened to hear Andrea Bocelli, the blind kind-of-sort-of tenor, boast on TV that he used to sneak out of his houseduring the lockdown. Ummm, might that explain why he and his entire family got sick with COVID-19? Says Bocelli: “I know lots of people, and I don’t know anybody who wound up in intensive care. So who says it’s serious?”
None of this comes anywhere near the levels of protest and resistance seen in the United States, though, or even Germany – there unmasked and crowded tens of thousands turn out for protests waving Imperial cum Nazi flags and hoping that Donald Trump will “Save them all.” A right-wing COVID-denier Rome demo on September 5th drew only 1500 people.
|COVID denier demo in Germany|
At bottom, Italians may simply have more common sense than Germans. Just take a look at pictures of those right-wing rallies. Even at Salvini’s blame-the-immigrants open-it-up events you can see plenty of masks, though admittedly not all cover the nose.
|Matteo Salvini COVID denier demo in Ventimiglia|
So glad to have your reliable posts, they provide thorough updates, and in spite of no great solutions yet, I know you will research, weigh, and inform as soon as there are. Take care!ReplyDelete
Thanks so much. I'm certainly praying for a breakthrough - or would be if I were the praying sort!Delete
Great update, Susan! As you know, I've been following your reports on Facebook, as well as the usual dailies (La Repubblica, La Provincia Pavese, Corriere, etc.) and my friends in Lombardy. That said, I really appreciate your filling in the blanks. Be safe!ReplyDelete
Thanks, John. I have to confess I don't read the Italian papers regularly anymore and never watch TV so, more than usual, a lot of what I wrote in this particular post is impression and observation.Delete
Yet again a leronlimab study being touted by its manufacturer without any data. This time in fact there's even less than the first time, when Cytodyn said the drug might have saved the lives of 4 patients. Gotta wait for the data to be published; unfortunately this class of drug is very unlikely to be a game-changer. But we can hope!Delete
really appreciate your observations! well done.....totally agreeReplyDelete
I can't be completely sure that this is a genuine comment because it's so vague. But I think I'll take it as a heartfelt compliment and will thank the unknown author.Delete
Such a thorough description of COVID developments. You put a lot of work into this!! Much obliged, Susan.ReplyDelete
Thanks a lot, David.Delete
Really good read and very informative. Thank you.ReplyDelete
Regarding your skepticism of masks, have you seen this?ReplyDelete
Basic science behind using masks to reduce transmission of COVID19
No, I didn't see this. Dr. Williamson is, as she explains, not an expert in anything medical. I have followed the literature regarding masks, aerosols, and COVID-19 very closely. The best evidence we have is that physical distancing is much more important than masks, though the latter may contribute a little. And the most convincing article supporting aerosol transmission over large distances, which had to do with an outbreak on a bus, has been withdrawn as scientifically invalid. So I remain unconvinced on both fronts.Delete
How about research cited here (slide 18)? https://drive.google.com/file/d/1ZaiDO87me4puBte-8VytcSRtpQ3PVpkK/viewReplyDelete
Slide 18 includes the sole study showing value in COVID-19 specifically: "Masks reduce flu transmission within households by 60-80% (ref 3)." In that study, masks worn by household contacts during the days BEFORE a patient became sick with COVID were very protective. I strongly recommend that anybody who tests swab positive and all their household members wear masks as well as physically separating the positive case.Delete
Also, research here - http://www.healthdata.org/infographic/covid19-mask-usage-meta-analysisReplyDelete
Most of this stuff is speculation. Actual studies of COVID do not support wearing masks outdoors except in exceptional circumstances (e.g. packed political rallies). I certainly support wearing masks indoors in most public settings, but physical distancing and ventilation are far more important. Not to sound like a broken record, but I have observed time and time again that people wearing masks very often act in practice as though they were protected by that fact alone, which is very dangerous.Delete
I haven't dug into the data, but the infographic references a meta-analysis of 20 studies, which I'm assuming are epidemiological country comparisons (i.e., data-driven models, not speculation). Clearly environmental conditions (indoor v outdoor) and human density are relevant, but according to their models, "Mask use can reduce transmission by 30% or more." https://covid19.healthdata.org/global?view=mask-use&tab=trendDelete
How effective are masks?
Our analysis indicates that masks, whether cloth or medical grade, can reduce infections for mask-wearers by at least one-third. To learn more, visit our estimation update published on June 25, 2020, specifically the heading “Why masks? How effective are masks?”
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What is the mask use chart showing?
This chart compares the current level of mask use in a location to the universal mask use target (95% mask use). Mask use is defined as the percentage of people who say they always wear a mask when going out in public. The target of 95% mask use is the highest level of mask use in the world, found in Singapore. Our data sources for mask use are listed here under "Where does IHME obtain its data?".
As the healthdata.org page points out, "Social distancing mandates are more effective than masks at reducing infections." All I am saying is that keeping a meter or ideally 2 between people, and maximizing ventilation, are what is fundamental. Masks do add some protection indoors but must not be used to substitute for those primary measures.Delete