Glossary

• Virus– a type of germ that consists solely of a bit of genetic material (DNA or RNA) wrapped in a protein coat.  The coat gets the genes into the target cell where the genes force the cell to make zillions of new viruses, and on it goes.
• Coronavirus– a species name of a number of different viruses.  Called corona because its protein coat is studded with spike shapes that form a crown, halo, or corona of spikes
• SARS-CoV-2– the specific name of the new coronavirus
• COVID-19-the name of the illness that the new coronavirus is causing
• Endemic– an illness always present in a region.  One could say strep throat is endemic in the US
• Epidemic– a sudden burst of an illness that comes and goes over a limited time
• Pandemic– an epidemic that bursts across the world not just one region
• Spreadability– how contagious is the disease, how many people will end up infected
• Symptoms- the experience of being ill, for example- fever, cough, headaches, loss of smell etc.
  • Asymptomatic– literally means “without symptoms”.  For COVID-19 it refers a person infected with the virus but has no and will have not symptoms
  • Presymptomatic– This is a person who was infected with SARS-CoV-2, and will feel sick, but hasn’t yet
• Severity– what harm does the disease cause, in terms of  how sick you get and how many it will kill
• Mask- a mask is a loose-fitting cloth or textile that covers the mouth and nose loosely.  A surgical mask is a mask used in surgery
• Respirator-  for the purposes of the COVID-19 pandemic and other respiratory illnesses, a respirator is a mask that fits very snugly or tightly to the user’s face.  An N95 mask is a respirator.
• Personal Protective Equipment (PPE)- PPE are any item that covers any part of the body with the design and intent of keeping viruses in the environment from infecting the wearer of the PPE. PPE’s include all masks (which includes respirators), face shields, eye shields, gloves, gowns.
• Ventilator- a ventilator is a machine that can force a person unable to breathe to inhale and exhale and control both effectively.  They are sometimes called respirators, but during this pandemic the word respirator is now reserved for reference to a tightly fit mask.
• Live Virus Swab– this is the swab which attempts to swipe live virus from one’s nose or throat to see if you are currently infected.
• Antibody Test- (aka serology test) this is the blood test which looks for antibody to the SARS-CoV-2 virus to see if you have been infected in the past.

An Urgent Word on the Threat of Nonsense in a Pandemic

Yesterday the American White House forced through emergency approval of an unproven treatment.

We should repeat three pairs of words in that sentence that sound the alarm to all who care about truth in medicine:

• White House
• Force through
• Unproven treatment

Let’s take a step back and consider the path to finding treatments that really work.  It is very, very difficult.

We often teach science as the story of a loan genius suddenly having a Eureka moment, forever changing the lives of humanity.  The most famous example is Isaac Newton lounging around under an apple tree when an apple drops and suddenly the entire notion of the theory of gravity sprouts from his mind in an instant.   This model of the work of science is very powerful, and fun to think about.  It makes us think of nice ideas like heroism, and that all it takes to improve our lives is for lightning to strike, and voila, it happens.

We still think this way.  The discovery of a polio vaccine suddenly appeared to Jonas Salk, who was worshipped as a hero for suddenly ending polio.

But this is not how science works!  A great example is the work on penicillin.  The story goes that Alexander Fleming saw some plates growing bacteria in his lab contaminated by mold.  Instead of throwing them away as dirty, he had a Eureka moment and had a piercing insight that the mold killed the bacteria.   But that’s not what happened.  He did notice his plates had mold on them in 1928.  He published the observation that something in this mold killed deadly bacteria in 1929, but he couldn’t find a way to grow the mold in a way that he could extract whatever was killing the bacteria and concluded there was nothing of value to medicine here.  It was his assistants Florey and Chain who found a path to penicillin.  They started their work in 1935, seven years after the discovery.  And the first patient wasn’t treated with penicillin until 1941,13 years after the discovery.

If the Prime Minister of Great Britain had announced, with no evidence, that Britain had a path to use the penicillium mold to cure all bacterial infections in 1928, no one would have been cured, and the path to find a way to manufacture penicillin would have been set back, hurt.

Science does not occur in lightning strokes, it happens with honest, hard work, really much like anything we do as people.  Things of value take hard work to bring to life.

The Truth on Convalescent Plasma

So, if a White House forcing through an unproven treatment is a sure fire path to confusion, not cures, what is the current truth about convalescent plasma?

First, what is convalescent plasma?

That turns out to be the easiest question to answer.  Plasma is simply the liquid part of blood, which is a combination of cells and liquid.   Serum is another word for the liquid part of blood, but it is the liquid minus the clotting proteins.

Now why convalescent?

Since the late 1800’s science has known that for many illnesses, after a person (or any mammal) experiences that illness, their blood will have a surge of antibodies that destroy that infection circulating.   The Cleveland Museum of Natural History has a stuffed animal memorial to the dog Balto, who led a mush team in Alaska to get a batch of blood plasma, or serum, from people who have recovered from diphtheria to the distant village of Nome where a deadly outbreak of diphtheria was raging.  Balto got the convalescent serum there in time, saved lives.  It saved lives because people recovering from diphtheria make loads of antibody that really does wipe out the infection diphtheria.

So convalescent plasma is the liquid part of the blood from people who have had a disease, with hopes that it contains antibody, and that tranfusing that plasma will deliver an antibody that will cure the infection.

Now we come to the key question, what do we know today about how well convalescent plasma works to cure COVID-19?  Will this plasma work like Balto’s serum to end a diphtheria plague?

Several points are known about convalescent plasma and COVID-19:

• The research is not yet done.  We haven’t yet done enough study to know if it works and how well it works
• People who get COVID-19 make antibodies to the virus.  But do these antibodies work?
• Studies of whether it works have been stymied by the drop in numbers tested for two reasons.
• The few studies completed show little benefit.  One study from Mayo Clinic shows a 2-3% improvement in outcome.

Let’s talk about a 2-3% improvement.  You might sense, that doesn’t sound like much, and if it turns out to be true, you would be right, 2-3% is a terribly disappointing level of benefit, very small.   But what does it mean.  Imagine a disease in which 5 million people get infected and 175,000 people end up dying.  If we dropped the number who died by say 3% then if we have another 5 million people get infected it will definitely help, only about 170,000 people will die.  The very good news is that it will save 5,250 lives, and that is astoundingly good news, but a treatment that improves outcomes by 2-3% will still let 170,000 people die, a pretty miserable failure on that score.

Now let’s talk about why studies are having trouble getting done.  One reason is very good.  Studies on treating COVID-19 only work if a community has a surge of COVID-19 raging.  You can’t easily study treatments for COVID-19 in NYC because almost no one has it there.  And studies tend to get started in cities or regions with lots of COVID-19 raging, but these surges wax and wane, and once the work of setting up the study is done, often the hot region cools, no study.

A very troubling reason studies on convalescent plasma are failing to get done, is the rush to use it.   No surprise here, it is very safe.  So why not use it. A 2-3% benefit is small, but it is something, why not try it, even if it turns out to really be a 0% benefit once all the facts are known?  And so people are flocking to use it.  That means the number of people willing to enter a trial and endure a 50% chance of getting the placebo, to compare it in the trial to the plasma, is dwindling.  If this trend continues we may never know if it works.

Now Back to the White House

This step of sudden claims we know the truth on this treatment is a classic case of harmful deception.

This step will create these potentially tragic realities:

• A rush to use convalescent plasma will only explode.
• That ruins chances to find out if it works
• Potential harms from an unproven therapy will take place with no one knowing

Basically, the key point is that if someone stands up, without sufficient facts, and declares the truth is known, the work to find the truth is crippled, and the chance of finding the truth often ruined.   We may now never really know if convalescent works, how well it works, and really if any harms come from it.

These points were made by the nation’s leading medical doctors on the subject, including Dr. Tony Fauci, last week, and their pleas seemed to succeed in having the White House agree to wait until we knew more, until yesterday.

We of course hope that convalescent plasma works, and it might.  But just as importantly, we want to know if it works.  There are no powerful goods that science has delivered, and there are many, that didn’t take hard work to create.  Let’s do that hard work, let’s find a real cure!

RETURNING TO SCHOOL

In our COVID-19 update from August 22, just two days ago, we cited Dr. Fauci’s line, 10%.  He stated that communities where the the number of people tested who are positive above which gatherings are very likely to erupt in outbreaks was 10%

The other expert whose expertise is precisely in the domain of pandemic science, Dr. Michael Osterholm, has measured a different number.  Dr. Fauci let us know a number above which opening schools will almost certainly cause flares, that number is the measure of what percent of tests done in your neighborhood run positive.

Dr. Osterholm has measured a different number, what number tells us that gathering, in any setting, is not likely to cause any outbreaks.   That is a different question that above what number will outbreaks be very, very likely.  This number tells us below what number will outbreaks be very, very unlikely.  That number is not percent of tests positive, but the number of cases spreading in a community in a day.  For Dr. Osterholm, if the number of people in a community have less than 1 case per 100,000 people, then, and only then will gathering happen with confidence that no outbreak will occur.   In Cuyahoga County, that would be a rate of 12 cases per day.  We are currently at about 600 cases per day on our county [see next section for details], 50 times over the level that gathering becomes safe.

These two numbers can easily cause confusion, but shouldn’t.

The two numbers are 10% and 1 in 100,000.

10% refers to the proportion of tested people who are positive.

1 in 100,000 refers to the number of people who are infected in a population.

The 10% is the number that tells us a danger line.  Dare to gather if the proportion tested who are positive is over 10%, and you will almost certainly experience deadly surges of COVID-19 in your community.

The 1 in 100,000 is the number that tells us the safety line.  Secure the rate of COVID-19 in your community to 1 in 100,000 infected or below, and gathering will almost certainly not cause deadly surges in COVID-19 in your community.

Where Are we at For the 10% and 1 in 100,000, the danger and safe numbers here in our Community?

In Cuyahoga County the number of reported cases hovered around 300 or so a day from March 27 until June 19.  Then a big surge occurred with cases per day soaring from 237 on June 19 up to 919 on July 17.  Since July 17 the number of cases per day has dropped to its current level of around 600 as of August 21.  Significantly, the % of tests taken for COVID-19 are down to 4% this week.

If we consider Dr. Fauci’s threshold of concern at 10% tests positive, and Cuyahoga County is at 4% and dropping, we are clearly under the level above which outbreaks are likely.  But at 600 cases a day, as noted above, we are at 50 times above the level under which outbreaks can be said to be unlikely with confidence

The key point is that as long as the SARS-CoV-2 virus is circulating, the more time, the more people, gather indoors, the more likely explosive outbreaks will reignite the whole cycle.   For schools that re-open during times of active transmission, like now, the responsibility is urgent that some mechanism, or process, be in place to catch likely outbreaks very, very early, before the numbers really do explode.   We are under the level that tragedy is very likely, but well above the level that tragedy is very unlikely.

TREATMENT

The Rapid COVID-19 Home Test- A Potential Breakthrough

One very promising development is cited by Dr. Michael Mina, Professor Epidemiology at Harvard.  He cites work on a “quick strip” that is cheap to make, about 85% accurate, can be bought in a pack like chewing gum, millions can be made with ease and sent to every home.   The idea is a complete transformation of testing for COVID-19 from a medical procedure that requires a doctor, hospital, or drug store, and move it to a quick, cheap test at home that can be done many times.  This new concept moves testing from seeing if someone might have it in particular situations- being sick, going to college, after an exposure- and move it to a frequent check-in.  One could see every American checking at home every other day.

If that happened, then the 85% accuracy would be drowned out by many tests, giving a highly reliable sense at any time one wanted, to know, do I or people I care for, have COVID-19?  And knowing you have it the day you become contagious opens the door to truly isolating as soon as you are contagious, THE path to stopping the virus.

This technology very realistically could allow us to all know that everyone around us is negative.  Schools, work, play, everything could become safe again, long before a vaccine arrives, and without any side effects.

I found this to be a dramatic development.   It is still under development, but once set, could be in high risk settings over a month and across the nation thereafter, stay tuned on this one.

In line with our discussion on convalescent plasma, let us let science to its work, let us let integrity guide the work, so we can find out if this idea will work, and how best to make it help us.

BOTTOM LINES

1. A very sad day for everyone who wants this pandemic to stop hurting us.  Science, our only path out of this catastrophe, was stymied yesterday, when the White House short-circuited the hunt to find out if convalescent plasma works.
2. As of today, we do not know if it works, and if it works how well it works,and what harms it may cause.  It looks like it helps to a minor degree, and looks like it may be safe, but now we may never know.
3. On re-opening school, we discussed the 10% level of danger that Dr. Fauci set, gather if your community has over 10% test positives and danger is very likely to erupt.  Today we share Dr. Osterholm’s safety number, control the epidemic so that fewer than 1 in 100,000 people are infected in your community, and gathering should be reliably safe.
4. Cuyahoga County is  under the danger line, but way outside the safe zone.   Gatherings such as in school are not certain to cause deadly surges of COVID-19, but we cannot be confident that this will not occur.
5. A new fairly safe and simple test idea might just change the whole conversation on COVID-19.  Not yet proven, needs more work to refine and prove if it works.  But IF it works, a cheap home test for COVID-19 might allow everyone to test very frequently.  We might just have a tool that lets everyone infected know the first day they are infected, allowing all infected to isolate, and stop the spread of this terrible disease.  IF that happens, then we could confidently know everyone at school, at work, at play, is not contagious.  A great hope.

We of course hope this torment ends.  We hope all new ideas for treatment cure everyone, for testing allow us to know in the moment who is contagious and who is not.   Science will deliver, but let us let science do its work, and then enjoy the fruits of those labors and really see our troubles end. 

To your health,
Dr. Arthur Lavin