Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Monday, September 09, 2019

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. 

Monday, May 30, 2016

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.  

Monday, July 23, 2012

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.