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Working flat out to produce possibly unnecessary ventilators
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We learn more all the time about
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
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.
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