Breathing While Black: Discrimination By Pulse Oximeters

 

For several years now, you have been able to go to your local drugstore and buy for less than $50 a device called a pulse oximeter.  It's a little thing you clip on your finger, and in a few seconds it displays two numbers.  One is your pulse rate, and the other is supposed to be the percent of maximum capacity of oxygen that your blood is carrying.  Most healthy people show a blood-oxygen percentage of around 98%, but anything considerably less than that means you're not getting enough oxygen to your tissues.

 

Hospitals and doctors have more sophisticated versions of these devices, but apparently they all share the same flaw these days:  they can give falsely reassuring readings on people whose skin has significant melanin content.  Black people, in other words.  So for decades, anyone in that category whose blood oxygen has been monitored with a pulse oximeter has been in danger of going untreated for low blood oxygen, compared to a person whose skin was lighter. 

 

This is not news.  The problem has been known for decades, but received added publicity during the COVID-19 pandemic.  Studies have shown that people of color receive less supplemental oxygen than average during medical treatment, and bad pulse-oximeter readings only exacerbate this problem. 

 

Fortunately, some engineers at Brown University are trying to address the problem.  In a report carried by the health-information site Statnews, Kimani Toussaint, a Black professor of engineering, is reported to be working with students on a patentable idea that will lead to pulse oximeters that give the correct reading no matter who is being tested, and what color their skin is. 

 

I wish them well, and hope that they can make a significant difference in what has to be one of the most embarrassing deficiencies in healthcare technology to come to light in years. 

 

It didn't have to turn out this way.  The same article cites a report in Wired on one of the first oximeters to hit the market way back in the 1970s, developed by what was then a medical branch of the instrumentation company Hewlett-Packard.  In their typically thorough way, H-P included 248 people of color in their volunteer pool of testing subjects, and made sure the readings were as good for them as for the other volunteers. 

 

Of course, the H-P device was a little fancier than the ones you get at Walgreen's.  It examined eight wavelengths of light, not one or two like the current ones do, and was about the size of a small beer cooler.  I'm sure it sold for more than fifty bucks, too.  But it got the oximetry ball rolling, and from that point on it was a question of how cheaply the device could be made, and whether inaccurate readings on a minority of the FDA-required sample population could be disregarded in the approval process, which they apparently were. 

 

I don't think anybody in the healthcare industry deliberately intended to make devices that discriminated in a purely technological way against people of color.  But beyond a certain point, ignorance was no longer an excuse, as studies were published describing the problem and cautioning clinicians not to trust readings of pulse oximeters with darker-skinned patients. 

 

But this is not a good solution.  The right fix, as Toussaint and his colleagues recognize, is to make pulse oximeters that work right for everybody, not just for white folks.  Supposing the Brown academics succeed (which seems pretty well guaranteed at some level, as H-P got it right in the 1970s with vastly inferior technology), what happens then? 

 

Like any industry, the healthcare-technology industry wants to make money and serve its customers as well as it can.  Compared to consumer products, devices sold for healthcare purposes are highly regulated and licensed, and jumping through the regulatory hoops is a cost that makes up a significant fraction of the price.  Unless the FDA insists on changing its rules so that pulse oximeters have to read equally accurately for all colors of patients, the industry doesn't have much of an incentive to adopt a newer technology that does that, whether it's patented by Brown or developed on their own.  For one thing, it means a whole new round of proof-testing and regulatory approval.  And for another thing, the market for pulse oximeters is probably not that big, and making a substantial investment in it for a benefit that will show up in only a minority of patients is a hard marketing sell.

 

I'm reluctant to use the phrase "systemic racism," but it might well apply in this case.  As I said, I don't think any individual manager or pulse-oximeter company set out to discriminate against people of color in developing devices that don't work quite as well for that group.  But somewhere along the long road of development between H-P's giant 1970s device and the $50 versions of today, somebody compromised some things and created the problem.  It would require a huge effort of investigative journalism and probably subpoenas to find out exactly how it happened, but the outcome is clear.

 

Sometimes, adverse publicity by itself will make an industry clean up its act.  Maybe if enough people of color ask questions of their clinicians about pulse oximeters, it will have an effect back up the supply chain and the companies will go to the trouble and expense of dealing with the issue.  But it's not going to happen automatically.  In the old days, a letter-writing campaign might have had some effect.  These days, social media is the obvious channel to use in letting people know there's a problem.  It's a pretty blunt instrument, though, a little like putting out a cigarette with a fire hose, and it can backfire on the user as well.

 

But as the Statnews article quoted Toussaint as saying, this problem is a poster child for increasing diversity in science.  If it's not a problem to you or people you know, you simply tend to ignore it.  Now that we know it's a problem—all of us engineers—I think it's time somebody should do something about it. 

 

Sources:  Statnews carried the article "‘A poster child’ for diversity in science: Black engineers work to fix long-ignored bias in oxygen readings" at https://www.statnews.com/2022/08/19/diversity-in-science-black-engineers-work-to-fix-long-ignored-bias-in-pulse-oximeters/.  The Wired article about the 1970s H-P oximeter is at https://www.wired.com/story/pulse-oximeters-equity/.

Juul and the FDA: Smoke and Mirrors

 

Full disclosure:  I have never smoked tobacco, pot, or e-cigarettes, so I have no personal dog in the following fight.  But lots of people do, and the story's twists and turns say a lot about the way the U. S. Food and Drug Administration (FDA) throws its weight around like a 900-pound gorilla that's had too many fermented bananas.

 

The newsworthy tip of this iceberg caught my attention earlier this week when the FDA issued a ban on the sale of all Juul e-cigarette products.  The reason was that after a two-year review of data provided by the company to the FDA, that august entity decided that on balance, there were not more health benefits than harms caused by the sales of that particular brand of e-cigarette. 

 

By the time I settled down to write this column, a U. S. federal appeals court in Washington had temporarily blocked the ban at the request of Juul.  The ban was not a ruling on the merits of the case, but lasts only until July 12 in order for the court to have time to consider the matter more thoroughly.  In case the court ruling went the other way, Juul had allegedly also been preparing to declare bankruptcy, as e-cigarettes make up the bulk of its products. 

 

Other e-cigarette firms have undergone the FDA's scrutiny and gained its approval as long ago as October of last year.  It's not clear why some companies have been approved while Juul, once the most popular brand of e-cigarette but now suffering from declining market share, was denied approval. 

 

What is even more striking is why the FDA allows the sale of conventional cigarettes by the millions, which everybody knows cause lung cancer and other fatal and debilitating diseases, and then turns around and says to Juul no, you can't sell e-cigarettes.

 

A look into the history of the FDA and tobacco shows a pattern of arbitrary regulatory overreach unevenly distributed among the various tobacco and tobacco-like products on the market.  Back in August of 2016, in the waning days of the Obama administration, the FDA gave itself authority to regulate all tobacco products.  If one asks "whence comes this authority?" the only answer I can think of is Congress, which set up the FDA in the first place to interdict the interstate sales of "adulterated" food and drug products back in 1906.  The FDA's authority to do so waxed and waned over time and court cases, but each time the headlines carried news about deaths due to things like impure vaccines, public opinion pushed Congress to authorize more authority for the agency.

 

But since World War II, we have seen the explosion of what is called the administrative state, in which agencies such as the FDA acquire a quasi-independent status and basically make up their own rules, with the frequent collusion of the courts and the passive acceptance of Congress, which either has other things to do or simply lacks the nerve to interfere.  So when the FDA took upon itself the mantle of authority over all tobacco products, the e-cigarette makers decided to make an end run around them.

 

Tobacco products have to start from tobacco.  The essential ingredient in e-cigarettes is nicotine, which the e-cigarette makers had formerly been extracting from tobacco.  That made their wares tobacco products and subject to the FDA's rules.  Well, what if they get totally away from tobacco and turn to synthetic nicotine made from, say, petrochemicals?  No tobacco, no regulation by the FDA.

 

This worked for a while, but even government agencies can figure out when they're being bamboozled.  So last March, tucked in a spending bill passed by Congress and signed by President Biden, a provision changed the FDA's definition of "tobacco product" to include those made with synthetic nicotine. 

 

Amanda Wheeler, president of the American Vapor Manufacturers Association, was quick to criticize the decision to reclassify e-cigarettes with synthetic nicotine:  “This bill ought to be called the Cigarette Protection Act, because the indisputable outcome will be countless more Americans pushed away from nicotine vaping and back into combustible smoking.”

 

Earlier, the FDA had decided that once it got authority to regulate e-cigarettes, the rule it would apply is this:  the supposed benefits of e-cigarettes, namely their tendency to keep people who would otherwise puff real cigarettes from doing so, had to outweigh the harms caused by the nicotine.  Now, how anyone would have the Solomonic wisdom and the utilitarian calculus ready to figure that out is beyond me.  But the FDA claims to have done it, favorably in the case of some e-cigarette companies examined last fall, and unfavorably in the case of Juul.

 

It really does begin to look like the FDA is a sock puppet whose manipulating hand leads straight to the big tobacco companies.  While those firms have moved into e-cigarettes to some degree, investing in or buying out vaping firms altogether, as a whole Big Tobacco would like e-cigarettes to go away and stop tempting people away from regular smoking. 

 

E-cigarettes, which rely on technical advances such as lithium-ion batteries, show the falsity of the oft-repeated saying, "Technology is neutral—only the way people use it is good or bad."  There is not a lot you can do with an e-cigarette besides smoke it.  As to the morality of smoking—e-cigarettes, regular cigarettes, pipes, or big stinky cigars—that is a matter fraught with complicated implications there is no space to examine here. 

 

But I think we can all agree that any agency with authority should apply that authority in a way that is transparent, logical, and fair.  The arbitrary ban of Juul from a market in which regular tobacco is permitted seems to fly in the face of that principle.  It will be interesting to see what the court of appeals decides once the smoke has cleared and all the facts are examined.  But without a firmer hand on the rein by Congress, the FDA will keep misbehaving in a way that destabilizes markets and perturbs the public it was established to serve.

 

Sources:  I referred to the following articles:  from Reuters via NBC News at https://www.nbcnews.com/business/consumer/juul-e-cigarette-sales-ban-on-hold-pending-federal-appeal-rcna35308, from Bloomberg News at https://www.bloomberg.com/news/articles/2022-06-23/juul-vaping-products-are-ordered-off-the-market-in-the-us-by-fda, from the FDA's website at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/fdas-deeming-regulations-e-cigarettes-cigars-and-all-other-tobacco-products, from Time Magazine at https://time.com/6156327/fda-synthetic-nicotine-regulation/, and from the Wikipedia article on Juul.

Social Media and the Fourth Deadly Sin

 

In case you're wondering, the fourth deadly sin in the classical lists of seven sins is envy.  Sociologist Anne Hendershott has written a whole book about it—The Politics of Envy—and the editors of the Spring 2021 issue of The Human Life Review excerpted part of a chapter that shows how social media sites such as Facebook and Instagram leverage this particular deadly sin to their advantage.  But not always to the advantage of the users, it turns out.

 

First, let's distinguish between envy and jealousy.  Although the two words are now used almost interchangeably, envy originally meant the feeling of resentment or anguish one person has when faced with another person's superior possessions or characteristics.  Envy requires a specific person to be envied, while a jealous husband, for instance, may not be worried about any particular other man interested in his wife—he's just suspicious of all of them. 

 

Hendershott points out that while envy has always been a part of the human condition, in times past it was limited to people you knew, or knew about.  But in the digital age, there are as many targets of potential envy as there are people on Facebook, and the opportunities for envy are multiplied indefinitely. 

 

Covetousness is related to envy, but in addition has the honor to be prohibited explicitly by God in Commandment No. 10 (or 9, if you're Catholic).  Advertisers have been exploiting covetousness for centuries, but until recently they had to do the tedious work of creating an artificially attractive and enviable portrayal for each ad:  "Here's this good-looking guy who just got the gal, and if you used his kind of toothpaste you could be where he is now." 

 

But with social media, all the Facebook techies have to do now is provide the proper tools, and people will naturally put their best faces forward in what Hendershott calls the "highlight-reel" version of themselves:  the best-looking picture taken at the party, the most expensive vacation setting, etc.  And envy is a strong motivator for certain other kinds of people to go and look at the enviable types, eat their hearts out, and in so doing add advertising revenue to the coffers of big tech.

 

What does envy do to the envious?  One would not expect a lot of positive effects, and several studies bear this out.  Hendershott says that a 2015 study carried out by a Denmark organization called the Happiness Research Institute found that people who take a break from social media report being happier.  Besides some studies that show a general inverse correlation between social-media use and happiness, another study of Danish teenagers found no strong correlation between the hours of social-media use and happiness.  Digging deeper, the researchers did find that the way social media was used did influence happiness. 

 

When they divided the users into active ones who posted a lot of material themselves, and passive ones who just poked around viewing the postings of others, then a big difference showed up.  The active users tended to be happier than the passive ones who just looked at friends' pages without posting much of their own lives.

 

Certain aspects of modern life seem to be inextricably tied to certain classic sins in a way that defeats their separation.  Where would modern capitalism be without greed, for instance?  Or advertising without covetousness?  Does this mean we simply have to shrug our shoulders and accept the harm caused by media-induced sin?  Or could something be done about it?

 

Just in the last week or so, I have read in different places some proposals to regulate social media, or at least the artificial-intelligence algorithms that are used to train users to be more reliable and complacent consumers of targeted advertising.  And I have also read strong arguments against such regulation, based mainly on the idea that any regulation of social-media content beyond what the private platform operators do themselves violates the First Amendment's protection of free speech. 

 

But when someone makes a one-to-one correspondence between, say, Patrick Henry making a speech before a crowd of fellow Virginians in 1774, and Cristiano Ronaldo, a professional Portuguese athlete who plays "football" (soccer in the U. S.) and is currently, according to Wikipedia.  the most-followed person on Facebook today with 148 million followers, I'd say we're definitely in apples-and-oranges territory, or maybe even apples and geodes.  What the comparison leaves out is the incredibly sophisticated AI-based machinery that Facebook and company use to train and otherwise manipulate both followers and leaders in modern social media—machinery that was entirely absent in the days before the Internet and electronic media in general.

 

The comparison that makes more sense to me is one between what the U. S. Food and Drug Administration (FDA) does today and what might be done by a similar governmental entity in the future.  The FDA came about largely because the sophisticated chemical adulterants used by manufacturers in the early 1900s were not something that your average consumer was even aware of, let alone could defend himself against.  So the FDA was charged with using the same advanced chemical and biological science available to the manufacturers to make sure that the foods and drugs sold to the public were not harmful, using a negotiated and agreed-on definition of harm.

 

It seems to me that given enough political good will (always a scarce commodity, but especially so today), we could define objective levels of psychological harm:  depression, anxiety, even rates of suicide.  And we might be able to determine to what extent these conditions were attributable, not simply to the user posts on social media, but the sophisticated methods used to heighten their impact on certain people who are thereby harmed.  And then we could go in and say to the tech companies, "This set of algorithms is okay, but that set is off-limits, because it leads to X suicides, Y instances of depression, Z cases of porn-induced erectile dysfunction, etc."  In order to do any good, the regulatory agency would have to have a cadre of sophisticated techie types just as smart as the ones the private companies have, and that might be hard.  But only such types can see through the opaque fog of algorithms to tell what's going on, and which ones are harmful.

 

Sources:  A portion of Chapter 9 of Anne Hendershott's The Politics of Envy (Crisis Publications, 2020) was reprinted as Appendix A (pp. 87-92) of the Spring 2021 edition of The Human Life Review.  I also referred to the Wikipedia pages on envy, jealousy, and Cristiano Ronaldo, who I had never heard of before today.

Do-It-Yourself Insulin?

For those of us with diabetes that is severe enough to require regular insulin injections, going without insulin is not a realistic option.  In the U. S., such people are at the mercy of the drug companies that make insulin, and they (or their insurance or governtment benefits, if they have any) have to pay whatever those companies charge.  A graph of insulin prices versus time gives a good imitation of an exponentially rising curve, increasing about 50% from 2014 to 2019.  A vial of insulin can cost today as much as $300, and as a result, many poorer diabetes patients are skipping doses and incurring complications from the disease such as infections and blindness.  For a drug whose inventor, Frederick Banting, refused to put his name on the patent because he thought it should belong to humanity, it looks like patients who need the drug to live are being gouged by Big Pharma.

An article in the May 25 issue of The New Yorker describes how some do-it-yourself-biology groups are trying to come up with an end run around this problem.  In "The Rogue Experimenters," Margaret Talbot interviews people at a meeting of the Open Insulin Project in Baltimore, where Ph. D's in biochemistry mingled with volunteers who set up DNA labs in their apartments.  Their goal is to engineer a bacterium to manufacture insulin, and make it available at a much lower cost than the big three U. S. manufacturers charge.  But even if the rather rag-tag group of professionals and volunteers succeed, they face huge hurdles in the form of the Food and Drug Administraion (FDA) approval process, which can cost millions of dollars.  The big drug companies like it that way, because it means that nobody much smaller than them can even hope to compete.

When asked about the high price of insulin, drug manufacturers point to patented improvements they have made over the years.  Each patent allows them to exclude competition, and while technically the U. S. market is not a monopoly, the only three significant insulin manufacturers operate what looks to this outside observer like a cartel, successfully defending their practices against attempts by government to break up the cartel.  But although one type of synthetic insulin introduced in 1996 has gone from $20 a unit to about $200 today, no one is claiming that it works ten times better than it used to.

A little historical perspective might help us see what is wrong here, and what might be done to fix it. 

Much if not most of modern medicine can be traced to two sources with Christian roots:  the tradition of charitable care, which gave birth to the modern hospital; and the tradition of scientific investigation, which led to the monumental achievements of medical science that makes medical care so effective today.  We sometimes forget how recently medicine has transformed itself from a sort of guesswork sideshow that only rich people could afford to a huge and largely effective enterprise that makes life better, or even just possible, for billions around the globe. 

As late as the 1950s, it was fair to say that while most doctors and drug companies were not hurting for cash, most of the people involved in medical care were in it primarily for reasons of love rather than money.  They wanted to help people, and a medical-related job or business did that.  This attitude explains Banting's willingness in the 1920s to forego what might have been a highly profitable patent in the interests of benefiting humanity.  But once medical science adopted the Big Science style made possible in other fields by government funding, enterprising business people found that if you made a drug that people had to have in order to live, they would pay almost whatever you charged for it.  And their patent lawyers found clever ways to prolong patents so as to exclude competition from this operation, which is a big part of how Big Pharma got where it is today.

Ah, but if all those profits hadn't been available to fund further research, would we have as many advanced drugs and medical technologies as we do today?  There is no way to tell for sure, but one thing that is certain is that the drug companies now look at medical needs mainly with an eye toward profit, rather than asking about who is suffering and what can be done about it?  This leads to situations such as "orphan drugs" that have small patient populations, have been around too long to patent, or are unprofitable for other reasons. 

This problem has been a long time in the making, and I'm not about to solve in it one column.  The biological do-it-yourself movement may lead to some changes, although if it gets to be a serious threat to Big Pharma, they can deploy herds of lawyers to manipulate the government regulatory system to put the DIY'ers out of business.  Government intervention of some kind may be helpful, but not simply by subsidizing whatever the drug companies charge, which is partly how we got here in the first place. 

Humanly speaking, any institution that gets too powerful and begins to exploit the public, needs to have an equally powerful force applied to it to make it quit.  That is why most of the solutions posed for this problem involve government intervention of one kind or another, because government (mainly meaning the federal government) is the only institution whose power and resources can compare with the multibillion-dollar multinational drug corporations.  There is some significance in the fact that although the U. S. insulin market is comparatively small compared to the rest of the world, the drug companies make about half of their insulin profits from that market alone.

And while it is perhaps a remote and forlorn hope, another thing that would help is if everyone involved in medicine—drug companies, hospitals, doctors, and yes, even patients—would recall the roots of the discipline in the motivation of the kind of love that wishes the best for the beloved, including healing.  Millions of ordinary health-care workers still have that self-sacrificial love, as the COVID-19 crisis has shown us in recent months.  But the marketplace is not a good place to look for love, so maybe we should start from a different place altogether in thinking about how to fix problems such as the high price of insulin.

Sources:  Margaret Talbot's article "The Rogue Experimenters" appeared on pp. 40-49 of the May 25, 2020 issue of The New Yorker.  I also referred to an article on the Vox website at https://www.vox.com/2019/4/3/18293950/why-is-insulin-so-expensive and a graph of diabetes care costs versus time at https://www.goodrx.com/blog/goodrx-list-price-index-rising-cost-of-diabetes-treatments/.

Vaping Turns Deadly

At this writing, three people have died and hundreds more have become ill from a mysterious lung ailment that is connected with certain types of e-cigarettes.  The victims typically have nausea or vomiting at first, then difficulty breathing.  Many end up in emergency rooms and hospitals because of lung damage.

Most of the sufferers are young people in their teens and twenties, and all were found to have been  using vaping products in the previous three months.  Many but not all were using e-cigarettes laced with THC, the active ingredient in marijuana.  Others were vaping only nicotine, but some early analysis indicates that a substance called vitamin-E acetate was found in many of the users' devices.  It's possible that this oily compound is at fault, but investigators at the U. S. Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) have not reached any conclusions yet. 

In fact, the two agencies have released different recommendations in response to the crisis.  The CDC is warning consumers to stay away from all e-cigarettes, but the FDA is limiting its cautions to those containing THC.  Regardless, it looks like the vaping party has received a damper that may change a lot of things.

So far, vaping and the e-cigarette industry is largely unregulated, unlike the tobacco industry.  It found its first mass market in China in the early 2000s.  The technology was made possible by the development of high-energy-density lithium batteries, among other things.  While vaporizers for medical use have been around since at least the 1920s, it wasn't possible to squeeze everything needed into a cigarette-size package until about fifteen years ago. 

Since then, vaping has taken off among young people.  A recent survey of  U. S. 12th-graders shows that about 20% of them have vaped in the last 30 days, and this is up from only about 11% in 2017, the sharpest two-year increase in the use of any drug that the National Institutes of Health has measured in its forty-some-odd year history of doing such surveys.

The ethical question of the hour is this:  has vaping become popular enough, mature enough, and dangerous enough, that some kind of regulation (either industrial self-policing or governmental oversight) is needed?  The answer doesn't hinge only on technical questions, but on one's political philosophy as well.

Take the extreme libertarian position, for example.  Libertarians start out by opposing all government activity of any kind, and then grudgingly allow certain unavoidable activities that are needed for a nation to be regarded as a nation:  national defense, for instance.  It's not reasonable to expect every household to defend itself against foreign aggression, so most libertarians admit the necessity of maintaining national defense in a collective way. 

           

But on an issue such as a consumer product, the libertarian view is "caveat emptor"—let the buyer beware.  If you choose to buy an off-brand e-cigarette because it promises to have more THC in it than the next guy's does, that's your business.  And if there's risk involved, well, people do all sorts of risky things that the government pays no attention to:  telling your wife "that dress makes you look fat" is one example that comes to mind. 

On the opposite extreme is the nanny-state model, favored generally by left-of-center partisans who see most private enterprises, especially large ones, as the enemy, and feel that government's responsibility is to even out the unfair advantage that huge companies have over the individual consumer.  These folks would regulate almost anything you buy, and have government-paid inspectors constantly checking for quality and value and so on. 

It's impractical to run your own bacteriological lab to inspect your own hamburgers and skim milk, so the government is supposed to do that for you.  Arguably, it's also impractical for vapers to take samples of their e-cigarette's goop and send it to a chemical lab for testing, and then decide on the basis of the results whether it's safe to use that particular product. 

My guess at this point is that sooner or later, probably sooner, the e-cigarette industry is going to find itself subject to government standards for something.  Exactly what isn't clear yet, because we do not yet know what exactly is causing the mysterious vaping illnesses and deaths.  But when we do, you can bet there will be lawsuits, at a minimum, and at least calls for regulation of the industry. 

Whether or not those calls are heeded will depend partly on the way the industry reacts.  Juul, currently the largest maker of vaping products, is one-third owned by the corporate entity formerly known as Philip Morris Companies.  In other words, the tobacco makers have seen the vaping handwriting on the wall, and are moving into the new business as their conventional tobacco product sales flatten or decline. 

The tobacco companies gained a prominent place in the Unethical Hall of Fame when they engaged in a decades-long campaign of disinformation to combat the idea that smoking could hurt or kill you, despite having inside information that it very well could.  In the face of an ongoing disaster such as the vaping illness, this ploy doesn't work so well.  But they could claim that only disreputable firms would sell vaping products that cause immediate harm, and pay for studies that show it's better than smoking and harmless for the vast majority of users.

Sometimes the hardest thing to do is be patient, and that's what we need to do right now, rather than rushing to conclusions that aren't supported by clinical evidence.  Investigators should eventually figure out what exactly is going on with the sick and dying vapers, and once we know that, we'll at least have something to act on.  Until then, if by chance anyone under 30 is reading this blog, take my advice:  leave those e-cigarettes alone. 

Sources: I referred to articles at CNBC.com (https://www.cnbc.com/2019/09/07/cdc-fda-clash-on-warning-consumers-during-lung-disease-outbreak.html) and vox.com (https://www.vox.com/science-and-health/2019/9/3/20847219/vaping-health-risks-2019-lung-damage-death) as well as the Wikipedia article on Juul.

Too Much Bang For the Buck: Exploding E-Cigarettes

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Last June, a man named Hamid Sadeghy was installing a car windshield in Austin, Texas when he felt a vibration in his pocket.  Sadeghy, who owns his own auto-glass company, is a responsible person who had been trying to cut back on his cigarette habit for the previous month or so by using electronic cigarettes (also called e-cigs or vapes).  Suddenly, in Sadeghy's words "It was like a firecracker.  It made the same exact noise.  A hissing sound and then burning sensation."  An e-cigarette in his pants pocket had exploded.  He suffered severe burns on his thigh which caused him to have difficulty walking, and was not able to return to work for three weeks following the accident. 

Sadeghy is one of dozens if not hundreds of people who have been affected by e-cigarette explosions.  Ironically, many people use e-cigarettes for the same reason Sadeghy did:  as a less harmful alternative to conventional smoking.  Although the jury is still out on the health hazards of e-cigarettes, there may be something to this idea.  But it changes the picture if every time you light up you're taking a chance that what you're smoking will turn into a pipe bomb.

The phenomenon of e-cigarettes showed up in the U. S. around 2007, and a 2015 poll showed that about 10% of U. S. adults now use the product at least occasionally. Vape shops have sprung up in many places, and most convenience stores carry them.  (Interestingly, the major tobacco companies dominate the convenience-store market channel.)  So if even a few hundred people have had their e-cigarette blow up on them, it is still a very rare occurrence, on the order of one incident per year for every 10,000 to 100,000 users.

Still, the tip of the injury iceberg of e-cigarettes is pretty grim, not to mention the property damage caused by fires.  A recent article on Buzzfeed shows graphic photos of Joseph Cavins, whose exploding e-cigarette destroyed one eye, and Thomas Boes, who lost three teeth in a disfiguring explosion from the same cause.  It's not clear whether such highly publicized stories are responsible for a recent slowdown in the growth of the e-cigarette market, but it's certainly possible.  It's well known that a few really exotic and gruesome accidents can cause more popular fear than a much larger number of less chilling mishaps.  This is why some people will get in a car without thinking but refuse to fly under any circumstances, even though the risk of accidents per mile traveled are much greater in automobiles.

A federal agency called the U. S. Fire Administration (USFA) did a study in 2014 of accidents and fires caused by e-cigarettes, and found that about four out of five happened during charging.  Most of the units use a universal-type USB connector to charge the lithium-ion battery that provides the power to heat the vaporizing element.  Unfortunately, this connector will fit pretty much any USB outlet, including power sources that were not designed to charge the particular battery that the e-cigarette uses.  The USFA thinks that most of the fires happened when the user tried to charge their unit with a power source not designed for it.

Lithium-ion batteries are nasty chemically, even when they are not enclosed in a cylindrical metal structure that unintentionally forms a pipe bomb.  The electrolyte is flammable.  If such a battery is charged too fast, it overheats, the liquid electrolyte vaporizes and breaches the battery case, and the thing catches fire.  The fire raises the pressure inside the metal tube of the e-cigarette, and here's where the pipe-bomb analogy comes in.  Small tubes can contain much higher pressures than other shapes, and so the tube doesn't give out on the sides.  Instead, the end cap or caps blow off, but only after the pressure has built up to an extremely high level.  When a cap lets go, the flaming electrolyte shoots it off with the force of a projectile and sprays itself all over whatever is nearby.  If the unit's being charged, that may be only things like flammable paper or wood. 

But in the fairly rare cases when the battery fails while in use, this sequence of dire events can go off in your face, with tragic and disfiguring results.  Properly designed and manufactured lithium-ion batteries don't explode spontaneously as they are charged or discharged, but the technology is being pushed pretty hard even when an e-cigarette operates normally.  A current of an amp or more is needed to heat the vaporizing element, and some counterfeit or shoddily made batteries can't handle that reliably and end up with an internal short due to overheating.  The result is pretty much the same as with overcharging:  electrolyte vaporizing and an explosion.

The Buzzfeed report says that the U. S. Food and Drug Administration (FDA) is moving to regulate e-cigarettes, bringing them under the same regulatory umbrella as conventional tobacco products.  Their plan is to require sellers to apply for authorization to sell the units, with approval hinging on safety features such as overcharging protection circuitry.  Of course, this would make the units cost more, but the present situation that makes it easy to connect an e-cigarette to the wrong charger is clearly a bad one.

Fire has a way of showing up in the early stages of many electrical products.  For a few years I worked at a division of Motorola which made two-way radios for first responders, and learned something about the history of the company, which goes back to the early days of radios installed in automobiles around 1930.  Back then it seems that the company rushed some auto radios into production that were not sufficiently safety-tested, and the resulting burned-up cars nearly killed Motorola.  Fortunately, they figured out what was wrong and fixed it, and car radios became one of the company's mainstays for many years.

The vaping industry needs to clean up its safety act by changing the charging method so consumers can't accidentally make little time bombs by plugging an e-cigarette into the wrong charger.  This will require coordination among the dozens of largely Chinese e-cigarette makers that up to now are probably engaged in cut-throat competition, and may not happen unless the FDA imposes the requirement on them.  So it will be interesting to see what happens in that regard.  In the meantime, if you happen to be a vape-er (?), be sure to use only the charger that came with the unit.  And it might not be a bad idea to wear safety glasses while you smoke.

Sources:  I thank my wife for pointing out to me the article on Buzzfeed from which I learned of this problem, posted on May 26, 2016 at  

-->https://www.buzzfeed.com/josephbernstein/burned?utm_term=.tbvvL7kEL#.mr0E63qy6.  I also referred to a vaping website called IEC where an (admittedly unscientific) survey of thirty e-cigarette accidents is reported at http://info-electronic-cigarette.com/e-cigarette-explosions-an-in-depth-investigation/.  This site refers to the USFA study, which is available at https://www.usfa.fema.gov/downloads/pdf/publications/electronic_cigarettes.pdf.  Mr. Sadegh's story was reported by Fox News on June 30, 2015 at http://www.fox7austin.com/news/4664501-story, and the statistic that about 10% of U. S. adults use e-cigarettes is from http://www.reuters.com/article/us-usa-ecigarette-poll-analysis-idUSKBN0OQ0CA20150610.
Note added July 18, 2016:  A reader named Jason Artman read the above post and brought my attention to his website http://ecigone.com/featured/e-cigarette-explosions-comprehensive-list/, where he is maintaining a comprehensive list of over 100 e-cigarette explosion incidents.  

The Defibrillator That Fails May Be the One You Need

Everybody who has watched medical shows on TV has sooner or later witnessed a simulated attempt to start a heart going again with a defibrillator.  The doctor in charge tells everybody else to get out of the way—he places electrodes on the patient’s chest—then bang!—the body arches upward and, depending on what the dramatic needs of the moment are, either starts breathing again or gets covered up for the last time.  Used properly in real life, automated external defibrillators (AEDs, for short) can be lifesavers.

For a variety of reasons including circulatory problems and electrical shock, a person’s heart can go into an ineffective kind of twitching known as ventricular fibrillation, and blood basically ceases to flow.  This is called sudden cardiac arrest.  Invariably the person becomes unconscious and has no manually detectible pulse.  It used to be the case that unless properly equipped emergency workers arrived with an AED within four to six minutes of sudden cardiac arrest, it meant curtains.  Then it occurred to AED manufacturers to make their devices simple enough so even a sixth-grader could use one, as has been demonstrated in practice tests.  For the last fifteen years or so, easy-to-use AEDs have been showing up in public places such as airports, bus terminals, universities, and malls, and people have been rescued by quick-witted bystanders who grabbed an AED and used it in the right circumstances.  But as reported in IEEE Spectrum last spring, a disturbing number of AEDs out there fail to do their job, or would fail if called upon to work.

About 300,000 people in the U. S. alone die from sudden cardiac arrest each year.  Some  of these folks would not benefit from application of an AED, but many of them—possibly as many as 40,000 a year—could be saved by a properly applied working AED.  In Seattle, Washington, city authorities undertook to develop a registry of the location of every publicly accessible AED in town, and then promoted a “citizen defibrillation program” with advertisements, public information publications, and training.  The result is that as many as 45 percent of witnessed cardiac arrest cases (situations where the person is not alone) survive.  Contrast this to the U. S. average of 4 percent, or the even more dismal figure of 0.5 percent for Detroit.  The last thing anybody trying to use an AED expects is a little message on the machine’s display saying something like “BATTERY LOW” or “SELF-TEST ERROR 17.”  But it happens.

AEDs are medical devices, aren’t they?  And so they must go through the same rigorous Food and Drug Administration qualification and inspection tests as other medical devices, mustn’t they?  Well, not quite, it turns out.  AEDs are in a kind of legal gray area that allows manufacturers simply to say that their product is “substantially equivalent” to other AEDs, and then they can bypass the usual medical-equipment tests and qualifications.  So it’s up to the manufacturers to ensure that the batteries will stay charged and the unit will be operational even after years of total neglect, and perhaps environmentally harsh conditions of high and low temperatures and humidity in outdoor locations.

This would be a hard trial for any piece of electronics, but for a unit that someone’s life may eventually depend on, it’s doubly difficult.  And the Spectrum  report shows that an FDA investigation found over 90 percent of AED failures were not investigated sufficiently to identify the cause.  Most of these failures showed up during routine tests, but 750 of the reports of failure between 2005 and 2009 followed a death in which the AED was involved.  And at least one manufacturer maintained a “fix-on-fail” policy.  That is, when the same design problem began to show up in a number of calls for repair of AEDs, you would think the firm would act like most auto manufacturers do and issue a recall to all owners of that model device.  No—this outfit simply waited for the next failure to occur instead of notifying the owners of all potentially defective AEDs.

So what’s the answer?  Changing the law to make AEDs qualify through the same rigorous process as other medical devices is one alternative.  But the manufacturers claim, with some justification, that this will send prices (already in the $2000 per unit range) through the roof.  Ideally, an AED would be as cheap and reliable as a fire extinguisher so that people (for example, heart patients) could afford one at home.  But this isn’t going to happen if prices are north of two kilobucks a pop.

My libertarian streak makes me reluctant to say this, but the way we got fire extinguishers in every public building was by means of fire codes:  laws that compel building owners to have so many fire extinguishers for a given square footage of space.  And it’s the owners’ responsibility to make sure those extinguishers are operational too.  Maybe the only way to make sure AEDs work and are widely accessible is to pass similar codes requiring AEDs, at least in places where the demographics indicate it would be helpful.  Because people younger than 20 rarely go into ventricular fibrillation, for example, K-12 schools might not need more than one in a large building.  But rest homes, for example, could use more.

This issue strikes close to home for me, because as a 58-year-old male I’m in the prime demographic of those who might need an AED some day.  Both my grandfathers died of circulatory problems, and while I try to eat right and exercise, there’s only so much you can do.  Let’s hope the next time anyone you know needs a defibrillator, that one will be handy—and it will work, too.

Sources:  The article “A Shocking Truth” by Mark Harris appeared in the March 2012 issue of IEEE Spectrum, the general-interest publication of the Institute of Electrical and Electronics Engineers, on pp. 30-34 and 57-59.  I also consulted the Wikipedia article on defibrillators.