A Narrative: Coronavirus, Oxygen Monitors and the FDA

Working flat out to produce possibly unnecessary ventilators         

We learn more all the time about Covid-19 SARS-CoV-2.  Below are some pieces of the puzzle revealed just this month.

1.  From the Emergency Room

 A New York emergency doctor, Richard Levitan, shared his observations about the role of oxygen deprivation in a widely read New York Times piece several weeks ago.  From his discussion:

...(W)hen Covid pneumonia first strikes, patients don’t feel short of breath, even as their oxygen levels fall. And by the time they do, they have alarmingly low oxygen levels and moderate-to-severe pneumonia (as seen on chest X-rays). Normal oxygen saturation for most persons at sea level is 94 to 100 percent; Covid pneumonia patients I saw had oxygen saturations as low as 50 percent.

Patients compensate for the low oxygen in their blood by breathing faster and deeper — and this happens without their realizing it. This silent hypoxia, and the patient’s physiological response to it, causes even more inflammation and more air sacs to collapse, and the pneumonia worsens until oxygen levels plummet. In effect, patients are injuring their own lungs by breathing harder and harder. Twenty percent of Covid pneumonia patients then go on to a second and deadlier phase of lung injury. Fluid builds up and the lungs become stiff, carbon dioxide rises, and patients develop acute respiratory failure.

By the time patients have noticeable trouble breathing and present to the hospital with dangerously low oxygen levels, many will ultimately require a ventilator.

(Note:  The comment that patients compensate for hypoxia by breathing deeper may suggest why cigarette smokers have slightly better outcomes from this disease -- they've had more practice.)


2.  Behold the Oximeter

Dr. Levitan says that oximeters, cheap blood oxygen trackers that have been sold over the counter for decades, can be of great help -- informing people what is wrong when they are in the early or middle stages of this coronavirus.

Before reading his article, I had never heard of oximeters.  I learned only this week that a good friend keeps one by her bed.  She got it when she had pneumonia and after she had gone to the emergency room because she was having a hard time breathing.

Like many others, I am glad finally to know about oximeters now.  I definitely would consider getting one, but I'm pretty sure they are as difficult to find as toilet paper was last month.


3.  A Missed Chance

Curiously, if not for the US Food and Drug Administration and its tender concerns for our health, oximeters could have been available to many millions of people worldwide.

The agent of this availability would have been a surprising one: the Apple Watch, which tracks wearers' health information, starting with steps taken each day, to how much time is spent sitting or moving, to pulse rates, to exercise this year v. last year, and so on.

In fact, Apple Watches were designed and built with oximeters inside them, but these have NOT been hooked up for watch owners to use because getting FDA approval for such would have taken too long and delayed getting the products to market.

How this came about and why this is so is revealed in a somewhat cranky article published a few days ago.

Under current FDA regulation, the function is disabled. It’s another example of how federal regulation of the production and distribution of pharmaceuticals and medical devices in the United States is less focused on stopping viruses and other diseases than on blocking private-sector innovators from developing solutions that may not work or might have harmful side effects.

But, cranky or not, the article's point is fair.  Oximeters are time-tested, reliable and effective.  If the owners of Apple Watches were able to make use of those watches' oximeters, much good would have resulted.

Imagine if your grandfather had taken to his bed six weeks ago with a fever and a cough; imagine that you could put your watch on his wrist and, from it, learn that he was seriously oxygen-deprived.  You could have got him help before he needed to be put on a ventilator.  You possibly could have saved his life.

It doesn't take an imagination to grasp that this scenario could have played out in a non-trivial number of situations this year.  It would have helped many people.  At least at the margin, it could have reduced the demand for ventilators and the stress on emergency rooms and intensive care units.

Don't ask me why the FDA would require a lengthy permission and approval process for something so simple and basic.  What harm could it have done?


4.  Other Priorities

 The FDA continued to protect us from other health dangers even this week, when the number of US coronavirus deaths passed the 61,000 mark.

Just last Monday, when the entire economy was all but comatose, the FDA announced that it was sending warning letters to 10 different manufacturers ... of backpacks and sweatshirts.

"The public should really be outraged by these products," said Mitch Zeller, director of the FDA's Center for Tobacco Products, reports yet another article.

The products being targeted by the FDA ... (are) ... designed with stealth pockets to hold and conceal an e-cigarette; vaping products that resemble smartwatches or children's toys such as a portable video game system or fidget spinner; and vaping liquids that imitate packaging for food products that often are marketed and appeal to youth, such as candy, or feature cartoon characters like SpongeBob SquarePants.

Egads! Stealth pockets! Children being tempted by Sponge Bob to take up smokeless nicotine!  Where would we be without the FDA to protect us?

In fact, governments are all over the vapes industry.  Flavored vapes, apparently pitched to children, have been banned at the federal level and are being more extensively banned in various states.  A number of states' attorneys general are cuing up a great big civil suit, rather like the one that shook down the tobacco companies.  The biggest vape maker, Juul, also seems to be under financial stress.

Good to know the FDA is all over the fashion/toy end of the e-cigarette matter. 


5.  Comparable History

Could the FDA have gone a bit too far?

The FDA arose after the 1906 passage of the Pure Food and Drug Act of 1906.  The idea was to make sure that only pure products -- including cocaine, which was legal at the time -- were sold to American consumers.  (To my knowledge, the FDA has yet to take an interest in quantifying the THC strengths of ever-more-potent marijuana strains.)

In 1920 came the Volstead Act, a Constitutional amendment known as Prohibition, a failed effort to rid the country of alcoholic beverages.  Prohibition ended in 1933 when the state legislature of Utah (Utah!) provided the final vote to repeal it.

Between 1920 and 1933 people innovated to conceal their illegal alcohol.  Among the popular products were slim flasks to carry distilled spirits.  For men there were flasks that fit in the breast pocket of business jackets and hip flasks for the back pockets of trousers.  Some women wore stocking flasks on their legs

At right is an image of men of that period enjoying liquor from a flask in broad daylight.  Can you imagine?

If our current activist FDA existed at that time, there would be investigations and prosecutions of flask manufacturers and, then, demands that pockets be eliminated from men's jackets and trousers.  Just for people's protection, of course.

In fact, the FDA mandate to regulate devices and associated products came long after Prohibition ended.

But just as ridding the world of alcohol flasks and flask pockets would have been widely resented a century ago, inspecting children's clothing in searches for "secret pockets" seems like a bit of a stretch today.


6.  The Sad Legacy

Back to Dr. Levitan, who wrote the commentary at top after 10 days in the emergency room at Bellevue Hospital.  (The piece merits a read in its entirety and is available online even to nonsubscribers.) Toward the end, he has this recommendation:

All patients who have tested positive for the coronavirus should have pulse oximetry monitoring for two weeks, the period during which Covid pneumonia typically develops. All persons with cough, fatigue and fevers should also have pulse oximeter monitoring even if they have not had virus testing, or even if their swab test was negative, because those tests are only about 70 percent accurate. A vast majority of Americans who have been exposed to the virus don’t know it.

If not for an FDA barrier, a serious portion of the world's 100 million Apple Watch wearers would know what an oximeter is.  Those same people could check their oxygen capacity if they fell ill this winter.  They could have shared what they knew, or shared their watches, with friends or relatives who got sick and who, like this writer, never knew that oximeters even existed.   Such information spreads fast, and it is extremely valuable in volatile situations like the current one.

We cannot guess at the numbers of people who would have got earlier treatment, who would not have ended up on ventilators and, yes, who would not have died if they learned in time that they were seriously oxygen-deprived.  All we know is that there are such persons and that having access to a simple health tracker in a wrist watch would have made all the difference to them.

I do not know if the FDA's slow-moving and process-heavy approach to approving a basic health-monitoring device was an error as serious an error as the CDC's slow, bungled and protocol-violating rollout of its failed Covid diagnostic test.  At best it was an opportunity squandered; at worst, it was an enormous blunder whose consequences have been revealed only this year.

Dead-End Testing

It’s the type of inertia that clearly frustrates Romer.  He calls the $2 trillion legislation passed by Congress “palliative care” for the economy. 

If you took $100 billion and put it into testing, 
he says, we would “be far better off.”

MIT Technology Review, April 8 2020

The article cited above makes more sense than almost anything else I have read about Covid-19 this year.  The quote is from NYU economist Paul Romer, who deserves more attention than our bumbling public health experts.

Here's the point:  If U.S. coronavirus testing had been handled better, fewer people would have died, many people would have been spared a miserable illness and the national economy might not be careening into what looks like a very deep, very expensive recession.  (More about the economy another day.)

So let's talk about testing, starting on January 20 of this year.

We all remember January 20.  That was the day the World Health Organization and China acknowledged, at long last, that Covid-19 was a contagious virus that was passed from person to person.  (This had been understood in China by December 6, 2019, and by everyone else not much later.)

Also on January 20, the United States and South Korea announced the diagnoses of their first Covid-19 patients.

The differences between the two countries' reactions -- specifically, their testing rollouts -- is worth a closer look.


South Korea

On January 27, when South Korea had a total of four patients, the South Korean Center for Disease Control sent an SOS to Korean medical labs, promising streamlined approvals for Covid detection tests.

The first test was approved on February 4, and a second one on the 12th.  By March 15, when a fifth test was approved, the country was testing 20,000 persons daily.  Daily diagnoses peaked at 909 on February 29, then dropped to 93 by March 18 and since then have rumbled at a very low level even as testing has continued, as seen below.

South Korean testers also contacted and tested the friends and neighbors of those who had tested positive, and almost every single member of a large church where hundreds of congregants had tested positive.  Because the tests had been given quick approval, their results were cross-checked against each other as the rollout continued, to assure validity.

In the world of disease prevention, these activities are known as Public Health 101.  South Korea now is manufacturing and providing Covid tests for many other countries.


United States

In the U.S., the CDC preferred initially to design and release its own test, starting February 4.  Four days later, reports began to surface about the test's unreliable results.

Another problem was the lack of tests.  Curiously, Kaiser Health News reports, the CDC distributed its first batch of tests in equal numbers to every one of the 50 states.  Sounds wacky to me, but, hey, I wasn't there.

On February 27, California's governor said the state had identified 33 persons with Covid-19 and was monitoring another 8,400 persons who had Covid-like symptoms.  Testing was going slowly, he said, because the state had only 200 CDC tests on hand. 

(NB: California is home to 40 million people, about 80 percent as many as live in South Korea.)

On February 29, the Food and Drug Administration gave its first go-ahead for non-CDC tests developed by pharmaceutical companies, universities and medical laboratories.

One week later, the U.S. had conducted 2,000 tests and South Korea 80,000.

There were other problems.  Because U.S. tests still were scarce, the CDC recommended testing only for people who had been to Wuhan or who had met people from Wuhan or who had Covid-type symptoms.

This approach did nothing to seek out people who had been in contact with sick Americans.  It did nothing to identify infected persons who were pre-symptomatic and contagious, let alone to tell such persons to isolate themselves.  Later, state by state, almost the entire U.S. population was ordered to quarantine, an edict with no end date in sight.

The US version of the Korean chart, above, mostly tells us how much later testing started here.  Its fast-rising trend line almost certainly reflects only the increasing numbers of tests performed; the inference that infections may have peaked in the last week (five weeks after the peak in South Korea) may be true or may indicate a lull in the daily availability of tests.

Worst, it tells us nothing about the number of infected persons in the country, because, again, testing was reserved for symptomatic people who were lucky enough to get access to tests (plus a good sampling of politicians, celebrities and tigers in a zoo; one of the last group was heard coughing and so six were tested "out of an abundance of caution.")   One hopes medical workers were given broad access to testing, but news reports suggest that may this may not have been the case.

In one perhaps typical case, the state of New Jersey, a domestic hot zone for the virus, set up a drive-through test site in late March.  When it opened at 8 a.m., the line of idling cars was miles long.  After 35 minutes, the line was closed because there were not enough tests for all the drivers who were waiting.  Testing stopped by noon.
           Last week, about six drive-through test days were announced in one New Jersey county, and persons with high temperatures and Covid symptoms were invited to make appointments for the limited number of tests available, roughly 100 to 250 per day.  The available appointments filled quickly, and 5,000 requests were denied.  Maybe in a couple weeks, or maybe in May ....

A friend shared the story of a Pennsylvania family man in his early 40s who ran a fever for two weeks and then got a Covid test whose results were promised four days later.  After two in-patient stints for major pulmonary interventions and after his second hospital discharge, he got his test result -- yes, he did have coronavirus.  Good to know, huh?

You can read more about these matters in articles from Reuters and the increasingly valuable Kaiser Health News.

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The conclusion here is this: After a late, slow start, the U.S. has piles of test results that reveal very little in the way of useful information.   We still have no idea how many people in the U.S. were infected, or are infected or might develop symptoms.  We never will know how many of this season's "flu deaths" were actually Covid-19 deaths.  If we have flattened the curve, it was by curtailing the movements of everyone for a period of time whose end we cannot forecast.

"The system is not really geared to what we need right now," the estimable and understated Dr. Anthony Fauci told a Congressional committee in March.

"That is a failing. Let's admit it."

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Given the cynicism engendered by the original testing program, it might sound odd to say this, but here goes:  The best hope for minimizing Covid damage in the U.S. is more tests.  

The new testing would be for antibodies.  Testing for such, done with pinprick blood samples, could identify people who are Covid-19 survivors and who have developed immunity to the virus.

Theoretically (and I do mean theoretically, given recent history) many of these tests could be done fast and yield answers within hours.  

The people who test positive for antibodies could go back to work and help start the revival of our comatose economy.  They could staff grocery stores, drive delivery vans, plow and harvest food crops and give medical workers some deserved relief.  They also could donate their plasma, which in very early testing has seemed to benefit seriously ill Covid patients.

This would NOT end basic coronavirus testing, however.  Those with no antibodies would need to be tested, probably repeatedly, for Covid infection and/or would need to remain quarantined until those slowpokes at the Department of Health and Human Services approve a Covid vaccine and get it to those who need it.  In a perverse way, those lucky enough to avoid infection will have to limit their movements until immunization provides their get-out-of-jail-free cards.

(In my dark imaginings, HHS will deploy Google to monitor the compliance of those without antibodies or immunizations by tracking them using data from their cellphones.  This capacity was revealed in recent weeks when residents of some cities were admonished for walking or driving too far from their houses and -- theoretically, again -- endangering others.  It doesn't take a Constitutional lawyer to wonder whether this isn't a Fourth Amendment violation.)

In any event, no immunization is expected to gain FDA approval for at least 18 months.  The restriction on movement during that period will be less popular than the proverbial ants at a picnic.


Note

Another upside to antibody tests -- again, IF we can organize and administer them -- would be establishing how many persons, if any, acquired antibodies without experiencing a traditional case of Covid-19.  The hope is that there are many of these people, but, again, we don't have the facts.  

Such tests also would answer a nagging question in the American West:  whether many Americans caught minor cases of Covid-19 and, with it, acquired immunity last winter.  There is a developing belief that minor Covid exposures lead to less serious cases, and the cases at issue arose and were resolved before very sick people began clogging hospitals, at least in New York, in mid February.   

This writer is one who would like the question answered.  I flew to California at the end of December and then coughed continually starting shortly afterward and for almost a month.  If what I had was a cold, it was a strange one (no stuffy nose, no fever) and my first in almost 20 years.  One of my siblings, in another state, had the same bug.  Another sibling flew out of a small town that later saw many Covid cases and arrived home with other odd symptoms.

For the record, if I do have coronavirus antibodies, I will be happy to donate as much plasma as I am able.