Is Vitamin E Acetate Killing Vapers?

Officials at the U. S. Centers for Disease Control announced Friday that they may have found a cause for the lung injuries and deaths in people who use e-cigarettes.  Since the problem arose last March, a total of 39 people have died from what is now being called "e-cigarette, or vaping, product use associated lung injury," (EVALI for short) and over 2,000 more have become ill or hospitalized.  A report by National Public Radio says that a compound called vitamin E acetate (tocopheryl acetate) has been found in lung-fluid samples from 29 individuals who were hospitalized as a result of vaping.  While the CDC has not reached any definite conclusions that vitamin E acetate is the sole cause of EVALI, the fact that it has been found in all 29 samples is significant.  The compound is known to be used by off-label manufacturers who sell vaping products containing THC—the active ingredient in marijuana.  Most but not all EVALI victims admit using vaping mixtures containing THC.

Vitamin E acetate is a more stable form of pure vitamin E (tocopherol), and the acetate is used in a wide variety of consumer products meant to be applied to the skin or swallowed.  It is an oil-like substance that is innocuous in these applications, but inhaling vaporized oily materials can lead to serious lung problems.  The syndrome called "lipoid pneumonia" can strike people whose job involves breathing vaporized oils.  For example, a performer who "eat sfire" by sticking flaming objects in his mouth will often prepare for his stunt by coating his mouth with a petroleum-jelly-like substance called kerdan.  If the hot object happens to vaporize some of the kerdan and the unfortunate performer breathes the vapor, the oil can coat the inside of his lungs and cause lipoid pneumonia.  A less exotic way of getting the disease is to take a mineral-oil laxative and have it go down your trachea instead of your esophagus (the wrong way.)  So it's entirely reasonable to believe that lipoid pneumonia is what the sick vapers are getting, and that vitamin E acetate may be the cause.

This situation is beginning to resemble another famous incident in which manufacturers involved in making a psychoactive substance turned to what they thought was a harmless chemical in order to cut corners, only to find that it poisoned their customers. 

During Prohibition in the U. S. (1919-1933), it was illegal to sell intoxicating beverages containing more than a few percent of ethyl alcohol.  One of the few exceptions was made for extracts of essential oils such as vanilla and ginger, which were typically 70% alcohol.  When sales of such products boomed and it became clear that people weren't just making lots of vanilla ice cream and gingerbread cookies with the extracts, the Food and Drug Administration required makers of these extracts to adjust their formulas so that they were undrinkable in concentrated form, a process called denaturing.  In particular, makers of Jamaica ginger had to add bitter-tasting substances like castor oil that would not interfere with the intended use for ginger flavoring, but would discourage would-be alcohol consumers from drinking the stuff just to get a buzz.  In order to enforce these rules, the FDA would audit samples of Jamaica ginger to make sure that when the alcohol boiled off, the remaining solids were heavy enough to satisfy the auditors that the makers were still denaturing their product properly.

Thus the matter stood until the price of castor oil went up in the late 1920s.  One Jamaica-ginger maker named Harry Gross looked around for a substitute chemical and found one called tri-ortho cresyl phosphate (TOCP for short).  He asked the manufacturer, Celluloid Corporation, if the chemical was toxic, and they told him they didn't think so.  But this was simply based on the fact that no one involved in the making of the chemical had become seriously ill, not that any tests on animals or humans had been made.  TOCP had a suitable specific gravity to be substituted for castor oil, so Gross made up a large batch of several barrels and sold it to retailers, who in turn sold it to their mostly poor customers who couldn't afford good bootleg liquor.

In a few months, doctors in the poorer areas of cities, especially in the South, began seeing patients whose legs were not working right.  It turned out that TOCP was a slow-acting neurotoxin that selectively attacked the nerves going to the leg muscles.  Over the next year or so, thousands of victims of what came to be called "jake-leg syndrome" turned up.  Many were permanently paralyzed and spent the rest of their lives in wheelchairs, if they could afford one. 

Gross eventually served a two-year jail sentence for adulterating his product, but there were no other major legal consequences for the manufacturers, or compensation benefits for the thousands of mostly poor victims of the syndrome. 

The parallels to the current vaping crisis may not be as obvious as they seem.  But in both cases, there is a chemical being sold under dubious circumstances by shady operators.  In both cases, the chemical involved was not previously suspected of being harmful.  And in both cases, serious injuries occurred to thousands of people before anything substantial was done to get to the source of the problem.

In contrast to the jake-leg episode, the CDC has been issuing warnings about vaping products almost since the first victims of EVALI were identified.  But the drive that some people feel to get high can overpower caution and common sense, and there will always be those around who are willing to cater to such desires with a potentially dangerous product.

It looks like the CDC may be getting to the bottom of the problem, and if they do, we can expect quick action against anyone selling vaping products that can harm users.  While the free market has its uses, regulations to protect the public typically arise only after serious widespread harm has been done due to lack of regulation, and that may be what happens in this case. 

Sources:  The NPR article "CDC Finds Possible Culprit In Outbreak Of Vaping-Related Lung Injuries" appeared on Nov. 8, 2019 at https://www.npr.org/sections/health-shots/2019/11/08/777646890/cdc-finds-possible-culprit-in-outbreak-of-vaping-related-lung-injuries.  I also used material from the health website Healthline at https://www.healthline.com/health/lipoid-pneumonia#causes.  I blogged on this matter on September 9, 2019 at https://engineeringethicsblog.blogspot.com/2019/09/vaping-turns-deadly.html.  And an excellent longer article detailing the saga of jake-leg syndrome ("Jake Leg" by Dan Baum) appeared in The New Yorker magazine's Sept. 15, 2003 issue beginning on p. 50, to which I referred for some of the information above, as well as Wikipedia articles on Jamaica ginger and vitamin E. 

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.

Handling Ebola Patients: An Engineering Problem

Two nurses who treated the late Ebola-virus victim Thomas Eric Duncan have been diagnosed with Ebola virus as well.  They treated him at the Texas Health Presbyterian Center hospital in Dallas, where he died on October 8 after traveling there from Liberia, where he acquired the virus.  Despite apparently following the protocols recommended by the U. S. Center for Disease Control (CDC) for dealing with patients with Ebola, nurses Nina Pham and Amber Joy Vinson are now being treated for the disease as well.  Their chances are grim:  the death rate from the virus can be as high as 50%. 

Besides all that, one could be excused from believing that nothing else is going on in the U. S. right now except the Ebola virus, at least judging from the media coverage in Texas.  If there is a futures market in Clorox, now's your chance.

We are used to thinking of technology only in terms of hardware, or maybe hardware and software.  But engineering designs can center around people and their behavior too.  The elaborate protocols and procedures that integrated-circuit manufacturers follow are just as essential to making their chips as the silicon is.  A roomful of advanced medical equipment is just so much scrap metal without the people and plans and procedures that can use them effectively.  And just as machines can be well or poorly designed, so can protocols.

Let's look at two protocols.  One is posted on the CDC website under the title "Infection Prevention and Control Recommendations for Hospitalized Patients with Known or Suspected Ebola Virus Disease in U.S. Hospitals."  That's pretty clear.  What do they say about personal protective equipment for the nurses and other personnel who care for Ebola patients?  It's pretty simple:  a face mask, eye protection (goggles or a face shield), gloves, and a gown ("fluid resistant or impermeable").  I don't know about you, but if I was within a few feet of a potential source of fluid that had a good chance of giving me a deadly illness, I would want to be covered by something more substantial than a "fluid-resistant" gown.

Now, let's consider another set of protocols.  In an editorial in the Oct. 16 Austin American-Statesman, critical care physician Bryan Fisk recalls the protocol he used when he was in charge of a Biosafety Level 4 Patient Isolation Suite at Ft. Detrick, Maryland.  This was a military facility designed to handle patients with diseases as dangerous as Ebola.  What kind of personal protective equipment did they use at this facility?  "[F]ully encapsulated positive-pressure protective suits with a tethered air supply."  In other words, a diving suit without the water.  Not only were they trained to do all sorts of procedures—intubation, catheterization—while wearing these undoubtedly cumbersome outfits.  Once they left the isolation unit, they underwent a complete chemical scrubdown while still wearing the suits, with the aid of other technicians.  And as long as they were treating the patient and for the length of the incubation period afterwards, they were confined to on-site quarters and not allowed to leave until there was no chance that they had acquired the virus.

There are reportedly about four of these types of isolation units in the U. S.  Understandably, they are more expensive than the standard emergency-room or intensive-care isolation units maintained by even the best public hospitals.  But in view of the fact that the CDC protocols, even if followed, fall far short of what the U. S. military does when dealing with Ebola-type situations, it's hard to resist the temptation to repeat an old consulting-engineer saying. 

The story goes that one day a consulting engineer gets a call from a factory manager where things are going haywire.  He flies out to the site, walks around a half hour or so, and then motions for the manager to come into a private office with him.  He sits down and says to the manager, "Your system is perfectly designed to give you the results you're getting."  In other words, you should not expect a badly designed protocol to deliver good results.

Fortunately, nurse Nina Pham has been transferred to a National Institutes of Allergy and Infectious Diseases isolation unit in Bethesda, Maryland.  I was unable to find any information on the protocols for protecting healthcare workers in that unit, but one hopes that it is better than the CDC's bare minimum. 

The perception of competence can be as important as actual competence.  Doctors and medical-care workers are some of the most trusted professionals in society, and when a scary thing like an Ebola case happens, the presumption is that those in charge will follow the best practices available to ensure that the disease doesn't spread.  With the failure of Texas Health Presbyterian Center to use adequate protocols, whether due to thinking that the CDC knew what it was talking about or otherwise, that trust has been severely damaged, and the word "panic" has started to show up in news items on the virus.  Professionals can be excessively reluctant to second-guess other professionals, but in this case it looks like it would have been better for someone in authority to order the Texas hospital to send Duncan to a military or equivalent-quality isolation unit the instant it became clear he was infected.  He might have died anyway, but we would have avoided any possibility that Ebola carriers were running around in public and flying in planes, which is the situation we face now.

Realistically, the risk of catching Ebola for the average person in the U. S. is virtually no higher than it was a month ago, which was approximately zero.  But already, serious damage has been done to the medical profession's reputation, and it will be some time before the fears of Ebola subside.  We can get there sooner if every organization involved with Ebola fully acknowledges the seriousness of the problem and spends the money and resources necessary to deal with it safely—or else admits they can't do it and defers to an organization that can. 

Sources:  Dr. Bryan Fisk's article "We need to send Ebola patients to U. S. disease-isolation facilities," appeared in the Oct. 16 edition of the Austin American-Statesman, p. A10.  The CDC's recommended protocol for Ebola appears at http://www.cdc.gov/vhf/ebola/hcp/infection-prevention-and-control-recommendations.html, and as of this writing was last updated Oct. 6.  The Dallas Morning News has a helpful timeline on Ebola in the U. S. at http://res.dallasnews.com/interactives/ebola-timeline/.