Politics + Science ≠ Political Science | COVID-19 Dispatch From the Field #14

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The words you speak become the house you live in. — Hafiz

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Winter is almost here.

It’s about to get real. Really real. The rural United States and most of Europe is on fire. We have no vaccine, no therapeutic and nascent testing. Our fast-paced, mobile and always-on version of modernity challenges our patience, amplifies uncertainty and attenuates our inherent altruism. If we don’t take a deep breath and a step back from politicizing science and a step forward with a nationally organized plan, we are in for a very rude third-wave awakening.

The current wave has many of the trappings of a tsunami. I was told in February, “Jordan, stop being such an alarmist talking about that virus, you’re going to get people anxious”. That was before New York, the lockdowns and over 220,000 dead Americans. I’m here to tell you, this winter will be a real shit storm if we do not collectively insist on embracing science and scientists, not politicians or politics.

There are reasons for optimism with a pending vaccine, a large pipeline of therapeutics and the creation of a burgeoning testing infrastructure. Moreover, the coasts are wearing masks and the case count is not spiking.

Yet, we are at the mercy of the actions and inactions of our political leaders. Scientists have been muzzled, sidelined and questioned. That is not how it is supposed to be. Science is a dialogue and a pedagogue, not a monologue by a demagogue.

I respect the effort of Operation Warp Speed to bring vaccines to the masses quickly; however, it is nearly impossible to rush a safety and efficacy study. They take real time. It’s like trying to make a baby by getting nine women pregnant for one month — you can’t. It just doesn’t work that way. It takes fullness of time and until that time, the best vaccine is a mask. Wear your vaccine.

The bottom line: you do NOT want to get COVID-19. Herd immunity has gotten some headlines, but so have the individuals afflicted by the poorly understood Long Haul Syndrome.

New research shows that early flu shots may lower your risk of getting COVID-19!

We need a congress for scientific progress; we must succeed, not concede or recede from the challenge in front of us. I desperately want to make this into a rap, but the virus is deadly serious so I’ll restrain myself for now.

Ultimately, I continue to strive for a narrative that emphasizes what is positive and actionable, while acknowledging our weaknesses, restores confidence in our institutions, celebrates our public servants and demands better from our public officials.

And the big question on everyone’s mind: How did President Trump and Chris Christy get COVID-19 and appear unscathed. We’ll get to that.

Please vote at the ballot box and vote for science — and if you enjoy my dispatches, please share them.

OK — let’s get to it:

WHAT WE KNOW — WHAT WE DON’T KNOW

What we DO know

• Weather doesn’t seem to affect transmissibility but colder weather tempts people to gather indoors.
• Outdoor transmission seems to be much lower than indoors.
• Life saving interventions still include wearing masks, physical distancing, hand-washing).
• Coronavirus does not spread easily from surfaces and you do not need to wash your groceries as we originally thought;
• A vigilance fatigue is setting in and people are letting their guard down.
• The complete SARS CoV-2 genome sequence.

What we KINDA know — but require much more knowledge

• The real effectiveness of the cocktail of monoclonal antibodies and Dexamethasone President Trump had on his recovery.
• The long term medical effects of COVID-19 in people who have recovered from the initial illness are coming into focus.
• The 460,000 person Sturgis Motorcycle rally was a super-duper-spreader event and likely a proximate cause for the current in the Dakotas.
• Wearing eyeglasses more than eight hours a day is protective against infection.
• Immunity may wane from those already infected.
• The risk of COVID-19 in children is low.
• Which pharmaceuticals are truly effective right now.

What we DON’T know — the blindspots

• What the peak of this new wave looks like
• How long the effects of a vaccine will last.
• How long we will have to live like this.

STATE OF THE COVID PANDEMIC

Straight up, not pretty. Belgium, Poland and the Czech Republic are running out of front line workers. Field hospitals are being set up in Wisconsin, Utah and North Dakota. El Paso has airlifting patients as far away as San Antonio. France and Ireland are back to curfews and circuit-breaker lockdowns are being implemented all over the place. Even the European exemplar, Germany, will be closing restaurants and bars starting and imposing curfews for the first time in 70 years. Almost every country in Europe is seeing steep rises in 14 day positivity rates- but it is France that appears to the epicenter with a 60% increase in seven day average new hospital admissions — 2,016 as of Tuesday. In the area around Paris, more than two thirds of the beds in intensive-care units are occupied by Covid-19 patients. The charts below should wake you up.

The projections are not pretty; here in the US and we experiencing record hospitalizations

For a state-by-state breakdown, visit the COVID tracking project to see how your state is doing. (Spoiler alert : more than 34 states are on the rise.)

…and the world isn’t faring much better with over 1.2 million dead and 44,000,000 cases reported and no slowing down. There are still over 5,000 people dying every day globally -

Are we winning?

See covid-19 rates in real time.

RISK GOING INTO WINTER

A new study in Nature concludes we could save 130,000 lives by the end of February 2021 if we all wear masks.

When the temperature drops, we tend to stay indoors. The critical questions regarding your risk over the next few months are: who is indoors with you, where did they come from, how is it ventilated and is everyone wearing masks?

We can talk about blood type, surfaces, mask wearing and general statistics but it makes more sense to look holistically at your risk quotient. That is, your overall risk can be distilled into the cumulative total of interactions with people; how close you were and how long you spent near them….and more importantly can you confidently prove they have not come from a hot spot or engaged in risky behavior.

Some risk metrics from New Scientist

• The risk of passing on the coronavirus inside a home is 10 times higher than that of passing it on in hospital, and 100 times higher than infecting others on public transport.
• 1 in 4000 is the risk of coronavirus infection passing between passengers on a full commercial flight. This drops to 1 in 8000 if the middle seat is left empty
• An 80-year-old is 1000 times more likely to die from covid-19 than a 20-year-old
• Men have about twice the risk of death from covid-19 compared with women

The Washington Post takes a deep look at the risk of transmission on surfaces. David Morens, a senior advisor to Fauci says, “There’s just a lot of unnecessary worry about these things,” he said. “It’s like standing in the middle of a busy freeway with traffic all around you and asking, ‘What’s the chance I’m going to get hit by a meteor?’ Now there’s a chance, but it’s pretty low, and don’t you have other better things to worry about?”.

That said, keep your hands clean, especially in locations where there are lots of other people coming and going that you don’t know.

Know what’s going on in your local community and bookmark this link to stay abreast of your local county to understand your geographical risk.

TESTING

In an alternative universe, we would be testing every student, employee and citizen all the time with pop up testing facilities in every community, school and business. The killer app and the hinge moment will be a rapid, inexpensive, point of care test that lives in your home. The FDA would have to make non-trivial regulatory changes to make this happen.

I am encouraged by the innovation and determination of testing companies to get to scale quickly. My snobbish science brain wants all tests to be highly accurate; both sensitive and specific; but at this point we just need something that has a decent risk/reward profile and can identify COVID-19 positive patients. The Journal Of the American Medical Association illuminates the challenges of expanding rapid testing by concluding that we will need 200,000,000 tests per month to curb this pandemic. We are currently at 21,000,000 per month.

The question I have for you is this: Would anyone refuse a test in the same way they refuse masks and vaccines? I believe that testing is less politically fraught with ideations of liberty being trampled. After all, is knowing your health status an intrusion on your civil liberties or useful information about the state of your health and your risk to others.

As mentioned in my last dispatch, the tests are coming.

The NIH continues to advance and invest in testing technology through their Rapid Acceleration of Diagnostics (RADx) initiative, which awarded contracts to six new biomedical diagnostic companies to support a range of new lab-based and point-of-care tests that could significantly increase the number, type and availability of tests.

Antigen Tests

Ellume USA — Two unique test cartridges contain a single-use, digital fluorescent immunoassay antigen test that returns accurate results in 15 minutes or less. One cartridge testing nasal swabs can be read out on two platforms by healthcare professionals, at the point of care or in laboratory settings for higher throughput. A second cartridge is being developed for home use with a self-administered nasal swab.

Luminostics — A rapid, smartphone-readout, antigen immunoassay that uses glow-in-the-dark nanomaterials to sensitively and specifically detect SARS-CoV-2 from shallow nasal swabs in 30 minutes or less, first for point-of-care use and later for home use

Quanterix — A laboratory antigen test with ultra-sensitive single-molecule immunoassay technology to enable detection from a variety of sample types including nasopharyngeal, saliva or self-acquired blood from a finger prick. Sample collection, transport, and processing will occur within 24–48 hours using existing sample collection logistics infrastructure through a network of centralized labs.

RNA Detection

Flambeau Diagnostics — A lab module that can be deployed in a mobile van to screen asymptomatic individuals to detect SARS-CoV-2 at low viral levels in saliva samples, returning results in as little as one hour. The system can serve employers, schools and underserved populations. It uses new extraction technology to purify and concentrate viral RNA reliably and quickly.

Ubiquitome — A battery-operated, mobile RT-PCR device that detects viral RNA with high accuracy in 40 minutes and reports results via its proprietary iPhone app. It offers high throughput and could be much lower cost than lab-based RT-PCR tests. The device is targeted for use in rural and metropolitan hospitals and mobile labs.

Visby Medical — A palm-sized, single-use RT-PCR device that detects viral RNA with highly accurate results at the point of care in 30 minutes. The device was designed to be used by a person with minimal skills. This novel, versatile technology platform can also be adapted to provide simple, rapid tests for other diseases such as chlamydia, gonorrhea, and influenza.

BOTTOM LINE: Tests are coming and they will make a huge difference. The more accurate the data, the less irrational the behavior.

VACCINES

WaPo

There’s lots of activity in this space. AstraZeneca and Johnson & Johnson are set to restart their vaccines efforts after a safety pause. Pfizer just announced their vaccine trial results will not be completed before election day (#NotSurprised)

Pfizer released a statement on 16 October saying that it will not apply for Emergency Use Authorization for its vaccine candidate until the third week of November at the earliest, when it will meet the FDA’s safety guideline of following trial participants for a minimum of two months after receiving their final dose. The FDA getting cold feet over issuing Emergency Use Authorizations for vaccines like has been done in the world of testing. Vaccines are tricky — they need to cause more good than harm…and this requires science.

The UK is asking for volunteers to sign up for Flucamp in the UK COVID Challenge. London’s Royal Free Hospital will infect up to 90 healthy subjects between 18 and 30 years old.

Back to those nine pregnant women:

The big questions for the vaccine hopefuls are:

1.When will the vaccine be proven effective and safe?

2. How much more effective than the US standard of 50 percent will it be?

3. When will the first post-approval vaccine dose be administered?

4. How many people will agree to take it and when would herd immunity be reached?

TREATMENTS

The U.S. FDA just approved the first COVID-19 therapeutic, Remdesivir at the same time the World Health Organization concluded, in their Solidarity mega-study, which enrolled more than 11,000 patients in 400 hospitals, that it is ineffective. In this trial, of the 2743 patients who received the drug, 11% died versus 11.2% in the control group. It’s important to get our orientation for treatments. I break it down into four based on time and symptoms: prophylactic treatment, early treatment, moderate disease treatment and severe disease treatment.

1. Prophylactic treatment — we have nothing now but the potential for hyperimmune globulins are a possibility.
2. Early treatment — we currently have nothing in this category; however it will be a great day when we do. Scientists are currently looking at antivirals, immune modulators, anticoagulants and immunotherapy.
3. Moderate disease treatment — the only EUA approved medications are Remdesivir, dexamethasone and convalescent plasma. Antivirals being investigated are monoclonal antibodies (Regeneron), which were administered to the president and Chris Christie, both subjects who are morbidly obese yet still standing, as well as immune modulators like Tocilizumab, Barcitinib and interferons along with anticoagulants. Lenzilumab is undergoing more clinical trials in the race for moderate disease treatment.
4. Severe disease treatment. Dexamethasone is the only EUA approved medication for severe disease. It’s worth noting that this potent steroid attenuates and compromises the immune system if taken early. That is, if people take this too early, it could be detrimental. Antivirals, immune modulators and anticoagulants are also still being investigated.

Sometime in November 2020, we will get reporting from eighteen trials on anti-virals, twelve trials on immune modulators and more clarity from other mega-trials across the globe.

In addition to all these medications, there are rafts of novel therapeutics in labs all around the world looking to tackle different mechanisms. Neutrolis, a treatment which attempts to tackle juvenile lupus, may have stumbled onto the root cause of immune dysfunction and might help ameliorate the Covid-19-induced cytokine storm and blood clots that commonly ensue upon infection. They believe that our own immune cells, neutrophils, create physical DNA spider-web like nets that wreak havoc in tissues. Their enzyme serves as a scissors to cut these webs and enable normal blood flow and immune response. Promising but we’ll see.

OVER THE COUNTER

Vitamin D: It’s safe and effective. Take it at night. There is more evidence that Vitamin D sufficiency equals less severe disease. I’ve found in testing my patients that there are still people with very low Vitamin D levels — ugh. Take a few at night, it certainly can’t hurt and could very well help.

Famotidine does not appear to decrease risk for mortality in COVID-19, according to an updated October 12 study of 7158 Hospitalized COVID-19 Patients from a Large Healthcare System

Melatonin: A new study suggests that Melatonin improves the outcome of patients when they are put on a ventilator. More research necessary.

Zinc : limited data.

BOTTOM LINE | The likely endgame for therapeutics will be a cocktail of anti-inflammatories, anti-virals, immune boosters, blood thinners, supplements and other agents that could really tamp down symptoms, morbidity, and mortality. We can look at HIV as an example for a successful cocktail to treat a complex virus.

IMMUNITY

How long does it last?

There is a high probability that once infected, we will have some version of lasting immunity up to a year. We will need the fullness of time to truly state this as fact. We know that 90 percent of people who recover develop antibodies, reinfections are extremely rare, and T-cell immunity has an important role to play. The counterpoint is that regular, common cold coronaviruses induce short-lived immunity and that their antibodies wane over time.

Herd Immunity

From an October 19th JAMA article “Herd immunity, also known as indirect protection, community immunity, or community protection, refers to the protection of susceptible individuals against an infection when a sufficiently large proportion of immune individuals exist in a population. In other words, herd immunity is the inability of infected individuals to propagate an epidemic outbreak due to lack of contact with sufficient numbers of susceptible individuals.” According to their models, it will take north of 60%, or 210,000,000 people infected before we can feel remotely comfortable that we’re getting close. To put this in perspective, the US has 8,500,000 million cases as I write this. We would need 200,000,000 people infected to get close to herd immunity.

WHAT ABOUT INFLUENZA?

A new study from China suggests that co-infection with influenza caused up to a 10,000-fold increase of coronavirus replication in human cells.

Get your flu shot!

TRAVEL

An October 1 article in JAMA on the risk of COVID-19 during air travel summarized it’s finding

“Wear a mask, don’t travel if you feel unwell, and limit carry-on baggage. Keep distance from others wherever possible; report to staff if someone is clearly unwell. If there is an overhead air nozzle, adjust it to point straight at your head and keep it on full. Stay seated if possible, and follow crew instructions. Wash or sanitize hands frequently and avoid touching your face.”

BOTTOM LINE | This may not be the thanksgiving holidays you thought you were going to have. Can you fathom taking a year off from holiday gatherings…just one year? The risk of hosting or attending an indoor family event is not trivial.

TRANSMISSION

“The Centers for Disease Control and Prevention on Wednesday expanded how it defines a “close contact” of someone with Covid-19 as it released new evidence showing the coronavirus can be passed during relatively brief interactions.

Previously, the CDC described a close contact as someone who spent 15 minutes or more within six feet of someone who was infectious. Now, the CDC says it’s someone who spent a cumulative 15 minutes or more within six feet of someone who was infectious over 24 hours, even if the time isn’t consecutive, according to an agency spokesperson.” Stat News breaks it down.

To add make matters more confusing, an October 20th study from the Vienna University of Technology believes that distance and masks are not enough.

“Masks are useful because they stop large droplets. And keeping a distance is useful as well. But our results show that neither of these measures can provide guaranteed protection”, says professor Alfredo Soldati. Just when we thought we had a handle on it.

And…

A room, a bar and a classroom -

How the coronavirus is spread through the air is a detailed piece on real world transmission experiments. Great explanations and videos — some static examples below.

CHILDREN & SCHOOL

The evidence is starting to point to kids younger than 10 years old have a lower risk of infection and lower transmission. As such, there is hope that 80% of K-5 schools will be open for full time, in person instruction by January. This of course, hinges on what happens with influenza.

Many schools are implementing a testing strategy to identify asymptomatic individuals while concurrently developing rapid response plans to contain outbreaks and prevent clusters.

Here is a dashboard of what is really happening out there. A sample here:

Fever Checks?

COVID-19 does not discriminate against signs, symptoms, organs or tissues. Survivor Corp, a collaboration with University of Indiana recently published a study, Fever Scans Offer False Sense of Security for Stopping the Spread of COVID-19. In their report, they conclude, “Fever checks do not detect the estimated 40% of people infected with COVID-19 who are asymptomatic”.

SYMPTOMS

THE SCIENTIFIC METHOD

Just for fun, let’s revisit it:

The scientific method is an empirical method of acquiring knowledge that has characterized the development of science since at least the 17th century. It involves careful observation, applying rigorous skepticism about what is observed, given that cognitive assumptions can distort how one interprets the observation. It involves formulating hypotheses, via induction, based on such observations; experimental and measurement-based testing of deductions drawn from the hypotheses; and refinement (or elimination) of the hypotheses based on the experimental findings. These are principles of the scientific method, as distinguished from a definitive series of steps applicable to all scientific enterprises.

This is contradistinction to the definition of politics:

Politics is the set of activities that are associated with making decisions in groups, or other forms of power relations between individuals, such as the distribution of resources or status.

Which is better at applying science; business or politics?

Nothing screws up a great story like data — Dan Covid Charts shows how politics impacts science in his partisan cases by state since June.

FINAL THOUGHTS

Returning to normal is going to be a gradual and incremental process. There does not appear to be any magic bullet that will suddenly change everything. The projections of 350–450,000 deaths by February is appalling. This is not American exceptionalism any of us is proud of. I’m trying to explain to my children how and why this could happen in the 21st century under our watch. History will not be kind to our leaders. Science must inform politics not the other way around. It’s crazy I even need to say this. Past experience suggests that many states and municipalities with rising caseloads will wait until their hospitals are at or over capacity to impose further restrictions — and only then will the non-mask wearers get a real chance to look in the mirror.

On a brighter note, two new studies show that there is a drop in mortality for COVID-19 patients in the US and UK across all ages, pre-existing conditions and racial groups. They believe the drop in mortality rates are the result of newly standardized treatment protocols, sufficient hospital capacity and more mask wearing.

As it gets more difficult to social distance outdoors in the cold and rainy weather, we are all going to need to take a deep look in the mirror and ask if Thanksgiving and holiday gatherings are worth dying for? In the long arc of humanity and civilization, taking a one year respite from the nostalgic and Hallmark Card-ian get-togethers is no brainer.

Regardless of what happens in the election, we must make a commitment to science and the scientific method, and put the pedal to the metal with respect to a massive, coordinated federal and local effort to integrate testing and treatments into every local community. We have lost too many. Are we willing to spend thousands of lives on flawed strategies and pseudoscience?

As for me? Well, winter is almost here and I’m a bit nervous. Most all companies have a mask mandate to protect their employees…why wouldn’t we consider doing this for the entire citizenry.

Stay warm, stay safe. Vote!

Dr. Jordan Shlain

PS — Here is my first spoken word poem: Pro or Con