Ideas for Useful Vapor Studies

We’ve seen some useless studies come down, but what are some useful studies that scientists could do to inform the public better about vaping?

Fine details on nicotine absorption

This will likely take a series of studies to gather enough data over various levels of vaping, but the gist is how do various vape parameters alter nicotine absorption rates?

Examples of the parameters involved include wattage/vapor density, technique of inhale/exhale (e.g., steal vaping versus cloud chasing versus “regular” vaping), and length of puffing session.

Unknown parameters might include modifications by ambient temperature, food, drink, circadian rhythm/oral mucus membrane’s biocycle, etc.

Also, how much does the same vaping regimen vary nicotine absorption between individuals? Are some subjects naturally more efficient at vapor-nicotine absorption than others?

Just-noticable Difference (JND) of nicotine levels

If a vaper uses a 12mg concentration, can they tell if they try an 11mg or 13mg? Does the JND vary with vapor density or other parameters above (it likely does with some)?

Understanding the JND may help with vapers that wish to lower or discontinue their vapor use. If they can step down at the right rate, it may improve their success.

It may also help manufacturers decide how to optimize their products. E.g., if an atomizer has a “hot start” feature that can increase vapor density for the first vapes of the day, it may help smokers that are reliant on that first cigarette but otherwise vape. If they can tell a smoker something like, “studies have shown that this increase in vapor density is equal to increasing the nicotine solution by x%,” it could help the vaper make a more informed choice about how to use the product to overcome their “first cigarette” issue.

It could also be used to innovate a dual-tank design where one tank is nicotine-free. If the user receives nicotine vapor for the first several puffs of a session, and the device then switches to the virgin liquid, is the session still satisfying?

Innovations in detecting nicotine absorption levels

Is there an easy-to-use proxy measure for measuring blood serum levels of nicotine? For example, can heart rate or blood pressure measures be sufficiently correlated to get a robust measure without blood draw? Such a finding could significantly improve the variety of studies done, as they would be simpler to design and conduct.

Investigations of dehydration

How much of an issue is dehydration? Can it be alleviated through using higher-density vapor with higher nicotine levels? Lower-density with higher levels? At this time the issues of dehydration appear to be anecdotal with no formal investigations. Are some individuals more vulnerable to the effect? Is it even a real effect (i.e., does vaping actually lower body hydration)?

These issues may not seem as profound as detecting formaldehyde, but each of them could positively help both public health and the vaping marketplace improve. For example, the FDA might require dehydration warnings on vaping products if the concern is great enough. But lacking evidence, the FDA apparently ignores that potential hazard entirely in their proposed rules.

Proper hydration is a real issue not just in daily health, but long-term avoidance of organ stone formation among other problems. It deserves to be given at least a cursory study if vaping is to be regulated.

Scientific Misunderstanding in Vaping Science

A letter published in the New England Journal of Medicine, “Hidden Formaldehyde in E-Cigarette Aerosols”, discusses an analysis on the production of formaldehyde from heating ecig liquids. And once again we have a scientific analysis that is based on a misunderstanding of the investigated system.

Their analysis showed high levels of formaldehyde production, but that finding directly resulted from overheating a tank system that was not designed for the test conditions. The authors were unaware of the constraints of the tested device, and they marched on believing that real people would use the device according to their test protocol.

These are likely very intelligent people, so how can they get it so wrong? They know a bit about chemistry and measurement and so on. But they failed to study the knowledge base they were working in. Not for a lack of its availability, what with the widespread information in the vaping community. For a lack of recognition that there is information they lacked.

They see a very simple system: fill with liquid, push a button, inhale. So we can measure what is inhaled. Oh, it has a dial that changes the voltage. We can see what they inhale at different voltages. Just as you can mismatch a light fixture with bulbs that fit but are not rated for the use, you can misuse ecigs.

There are other scientists doing meaningful work in this area. At the very least, these scientists could have consulted with those, agreed on protocols, and we could be on our way to having replicated results much sooner. Instead we have another dud of an investigation into formaldehyde in vaping, and we await the real results.

Formaldehyde is a known risk of vaping (one of the few), but an entirely avoidable risk as well. But we need the fine details of how much is produced under which conditions to know just how much effort is needed to eliminate the risk, and we do not have that data yet. And scientific misunderstanding, not knowing what they don’t know, muddies the water for safer products.

The other side of this debacle is that as these errors get repeated it hopefully raises scientific awareness of them. Future studies will focus more correctly on the real questions around vaping, and we will get our answers. It may take more time and money than necessary, but science tends to work like that. Indeed, I would not be surprised to see another half-dozen of these sorts of broken studies performed before the community-at-large clues in that this isn’t valuable information for science.

For a vaper it is a valuable lesson when they learn it themselves, in that they will tend to recreate the failed experiment and find it unpleasant and lower their power. The basis of a good vape is just enough heat and wicking to deliver a high-density vapor. Too much heat, an unvapable puff of formaldehyde. Too little heat, nothing to vape. Too much wicking, a gurgling, leaking pain-in-the-ass vape. Too little wicking, an unvapable puff of formaldehyde.

Vapers will naturally avoid all those conditions (or give up). The question for science is how big the margins are. How much formaldehyde can coincide with a good vape? And how do we eliminate it?

The Teetotaler’s Mentality

Vapers that keep up see bans all the time. Not just regular public indoor bans, but apartment bans and outdoor bans. It offends the liberty-minded vapers, but it confounds even the average liberal. Why do they go after vaping? Lacking any good basis, the tendency is to resort to conspiracy theories. Big Pharma and taxes are popular bogeymen. Or a liberal agenda trying to turn the world into a combination of Disney and 1984.

As I’ve talked about before, some in the public health community have a gross fetish for stomping on smokers, and many in the public have joined that cause. The mass paranoia that we live with today, where a whiff of tobacco smoke may set off a Goldbergian reaction that ends with the offendee dead, their children’s dentures embedded in their spine, while the little creeps sing MMMBop and play pingpong with their eyeballs. Point is, people don’t just hate smokers, they’re scared of smoke, too.

Public opinion has had so much poison crammed into the notion of smoking that anything close might just rub off. The notion of vaping as smoking is popular (even among some ex-smokers). There’s still addiction to nicotine and the behavior. There’s still inhalation and exhalation of a nebulous, semi-opaque cloud of chemicals (in the pejorative sense of the word). And the fear, the paranoia is that in some years scientists will discover that vapers have just been putting cigarettes inside of metal and plastic enclosures and smoking them. That’s really what these people are on about. Full stop.

Some literally believe vaping is smoking. Others believe that we will one day find out that it has long-term hazards just as great. And still others may believe that sticking feathers up their butt would make them into chickens. But vaporizing a liquid is different than burning a solid. It ain’t water vapor, but it is a vapor (a vapor of mostly polyols and diols (glycerol and propylene glycol, respectively)).

But fear is pernicious. It can cause the mind to lash out at things unrelated, at scapegoats. Vaping is a popular one today, because—facts check out—the anti-smoking movement has been a failure in many ways. It has been a failure of policy, of lawmaking, of compassion, of sense, from every village and hamlet, from every state and every city. Success is not merely an ends game, which the anti-smoking (really anti-tobacco and in some ways anti-nicotine) movement hasn’t succeeded in either, but as the saying goes, ‘it’s how you play.’

And the strategies and tactics have just been lousy. Not that the tobacco companies were cooperative, not that the politicians were humble, etc., but the movement as a whole hasn’t met the standards of a modern society. Its only saving grace has been science, what little science has been done compared to the money spent on pet projects and shoring up deficets due to lack of courage to raise the taxes.

The science of smoking and the public knowledge of it, fear of it, has had some success. But the science has always been overshadowed by the teetotaler’s mentality. This idea that abstinence is king, and we must all bow. We must all find it in our hearts to become masochists, to deny every vice that we have defined as vice (and yet to indulge the thousand others we have not yet defined as vice).

The teetotaler’s mentality is that holding a party with water and no beer is still a sin. Bingo is still gambling. Minced oaths are still curses. That veggie burgers are still murder. Contraception is abortion. And that vaping is still smoking.

They are zero tolerance, abstinence-only fiends. And they sometimes get the political ear to worry out a lame law. I still hold that in a decade a good many vaping bans will get reversed. But for now they keep coming. For now, the fearblind teetotalers have to change their diapers every time you vape.

But vaping is not smoking and no amount of agitprop will make vaping numbers drop off to levels where science won’t prove them much safer over the years. The teetotalers will find themselves prone on this issue, and many of these bans will get repealed as truth wears and tears at their jerking knees until they are stiff and arthritic.

Brick by Brick: The Final Stretch

We’re closing in on comments-due on 8 August 2014. If you haven’t commented, I urge you to do so by then. I will be submitting my own comment as well.

The process from 9 August 2014 is for the FDA to read all the comments they have not yet read, process them, and then formulate their new view of the matters at stake. Then they will amend the proposed regulation and it goes through the OMB loop again, letting them push back a bit. And then it eventually gets finalized.

Once finalized, the fun really starts. Lawyers of various stakeholders will begin helping them formulate their compliance behaviors for the new rules (larger and more established companies probably already have regulatory compliance work ongoing, but it will have to be modified and extended to fit the new rules). Lawyers will also begin considering how challenges to various provisions of the rules on various grounds might play out.

The provisions will all have effective dates, compliance periods, and so on. The companies will have to decide whether they want to force the issue on certain provisions by failing to comply entirely or let the FDA come after them for partial compliance, etc. Posturing will go on. The media will do whatever it is that they do. Throw darts at the proposal and print the words they land on?

But right now we still have time to finish our comments. For a little under a week, anyway. And then we get to wait for the final rule. Or maybe another comment period. If the FDA believes enough has changed once they reformulate, they could offer us another chance to comment, on an updated proposal. I actually think this may be the case.

We asked the FDA to extend the comment period, which they did. But they didn’t extend it very much. A very strange move, that. My guess is that either they don’t think the comments matter very much, or they feel that enough will change that spending too much time on first-round comments will be somewhat wasted. Given the comments do tend to matter, I lean toward the latter.

Keeping it short today, as I want to spend more time on my comment. Good luck!

Brick by Brick: Why E-cigarettes?

The FDA’s deeming regulations target electronic cigarettes. Much of the how of the regulations is by statute, originally meant to mainly cover tobacco cigarettes. The FDA gives an option in their proposal to largely exempt cigars that retail at over $10, on the premise that they are not likely to be smoked heavily by most of the population and especially by youth.

But why go after ecigs? That’s one choice the FDA does have, and is making, in their proposal. Aside from smokeless tobacco and cigarettes (and NRTs like the patch, which are exempt from the TCA as drug delivery devices), the FDA has discretion in which tobacco products to regulate. The question should be examined.

Foremost, vaping caught the FDA off guard back around 2007. At the time, some companies were making what the FDA (and likely the law) views as medical claims. The notion that you can quit smoking with some product makes it a medical matter, as smoking addiction is viewed as a medical problem (the disease model of addiction) that requires a medical solution. Never mind the fact you can write a book about ecigs, How to Quit Smoking with Electronic Cigarettes and the FDA can’t touch it. Or you can open the Church of the Electronic Cigarette and have people pray away their addiction while puffing on vaporizers and the FDA can’t do anything.

The FDA tried to take these companies to task, playing house detective for the pharmaceutical industry’s NRT and psychotropics meant to combat smoking addiction. The pharmaceutical industry does a lot of business with the FDA. The FDA believes all firms in similar businesses should therefore be subject to similar approval processes. This is both a feeling of fairness to the FDA and a way to guard their reputation; they need to believe their work matters: both that it both protects public health and that their labor is worthwhile.

Vaping won in court. The FDA could have shrugged it off, continued policing for medical claims, but leaving the vaping industry alone otherwise. Here’s where the inertia of bureaucracy kicks in. Having made overtures to regulate as NRTs, the FDA felt like they had to keep coming in whatever capacity remained. The perception of vaping as the latest stunt by the tobacco industry to skirt the 40-foot border fence put up to try to finally rid us of tobacco-related disease meant the FDA felt compelled to act. Out of internal pressures from the failed first attempt, out of media pressures, out of public health pressures, and out of political pressures, the FDA has to show they are up to the challenge.

It would be like if someone invented electronic food that gave the sensation of eating without gaining weight, and the health community came out, along with the legislators and executive agencies, demanding that we keep electronic food under a tight leash. They might do so on the premise that it would actually encourage more eating. They might say it will entice children to become over-eaters in the future. And, of course, they might say the risks of virtual food are unknown, unstudied. They would definitely say that we’ve been played by the food industry before (remember the TwinkieⓇ diet), and we can’t afford a repeat of that.

The problem is, even if there were problems with the current form of vaping (and there are no real indications of any major problems at present), the general goal and the technologies that exist can and should moot them. That is, the promise of vaping, even if it weren’t the reality, is entirely real. And even still there are members of Congress, employees of the FDA, and representatives of the public health community, that oppose vaping at its root on a variety of false premises (even Senator Tom Harkin of Iowa, political beneficiary and protector of the herbal supplements industry, showed confusion and lamentation that the FDA couldn’t regulate ecigs as drug delivery devices, something he would lose his seat for if he said it about herbal supplements).

Their main reason for opposition is the history of the tobacco industry. History they contributed to, mind you. The Tobacco Control Act largely protects the basic tobacco cigarette which is the main cause of tobacco-related disease and is the biggest seller of the tobacco industry. The TCA says that the tobacco cigarettes on sale as of 15 February 2007 may remain on the market despite any and all advances in technology (i.e., even if by some miracle biology invented a carcinogen-free combustion cigarette, the FDA would not be able to mandate the switch without a new law from Congress).

If anything, the TCA is built to impede progress. It requires an onerous process to garner approval for better, safer products. It requires an even harder road to make legitimate claims that a product is safer. Yet the world of perception that the media and the Congress live in says, ‘We have a law to protect us from tobacco, and e-cigarettes must be thereby regulated.’

The design isn’t necessarily meant to protect tobacco, but could just as easily have arisen from a desire to prevent what public health sees as tobacco’s ulterior motive of making deadlier, or at least more addictive, products. Yet it equally blocks safer, less addictive, or otherwise improved products all the same.