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The Community Safety Factor

Much has been written about why medicinal regulation of e-cigarettes is inappropriate and incorrect. Luckily we will not have to worry too much about these issues since all such regulation has been overturned by every court that hears a challenge to such commercially-purchased laws; thankfully the courts universally disagree that the pharmaceutical industry should be allowed to use the law as a commercial tool.

Clive Bates' excellent articles on why there are no good reasons for medicinal regulation of e-cigarettes, and why every argument for such regulation is fallacious, are worth reading:
http://www.clivebates.com/?p=1252
http://www.clivebates.com/?p=1351

Less has been written about how in the end the deliberate removal of e-cigarettes from the market in this way is doomed to failure because of the way the black market will take over, and because the government will eventually have to force the department involved to perform a U-turn (which has happened before, of course, in countries such as the US and UK). When 6 million people are using the black market to get safe products to stay alive, unjust laws cannot survive; a huge black market servicing just half that number of people would probably be impossible for the UK government to ignore and continue pretending that the law is "for the good of the people" rather than purely for commercial benefit. With around 1 million ecig users in the UK at Q2 2013, it is inevitable that by the time such regulations could be introduced there would be 3 million or so.

The exemplary safety record of e-cigarettes

Nothing at all, in contrast, has been written about some of the important factors that make e-cigarettes safe. This exceptional safety record is probably unique, and there are good reasons for its existence; the same factors do not apply anywhere else (and especially to medicines). There are factors that apply to e-cigarettes that are not seen anywhere else: they are entirely new and there is no way to recognise them in current regulatory processes.

One of these factors is typically unusual and has never been mentioned in the wider discussion on electronic cigarette safety or regulatory proposals: the consumer safety network. Because this is a new phenomenon and never seen before in the smoking / nicotine / NRT / pharmaceutical field, it has not been identified and its importance has not been recognised. However, it is a critical component of the unique safety profile of e-cigarettes and should be identified.

And note that PVs (e-cigarettes) do have a unique safety profile: if wine (or aspirin) were to be introduced today, and equally widely used, and equally closely monitored, it is impossible that it would achieve the same safety profile at this point in time. We regard wine or aspirin as harmless but needing sensible precautions in use; and there is nothing wrong with that at all.

The power of the web

There is a very large network of online e-cigarette consumers who are not just unusually engaged but strongly committed to supporting the community, product availability, product development, product choices and usage methods, community activism, and the reporting and discussion of health effects. The old way of describing it would have been that it is a fan base; but that wouldn't really be accurate as the community encompasses all aspects of the activity and includes professionals such as doctors, consultants (consultant physicians), lawyers, and professors of public health medicine, as well as senior nurses, chemists, engineers, journalists, politicians, advocates and activists among the very large and rapidly-growing user community. This is a natural feature when you consider that eventually it may include as much as a 20% cross-section of the population.

The forums, social media such as Facebook, Twitter and Reddit, the consumer associations, and the vapemeets (club meetings and conventions) are the components of the community's communication network; nothing like it exists for any similar consumer product area - there is no similar machinery for wine, coffee, chocolate, tea, cigarettes, cigars, smokeless tobacco, or cream cakes come to that; and certainly not for NRTs or other pharmaceuticals.

A forum may have 4,000 posts per day so it is quite clear there is an unusual level of engagement within this community. Every possible aspect of product choice and use is monitored closely by hundreds of thousands of people interacting closely. With 3 million ecig users in the USA, another 3 million plus in Europe, and up to 3 million more in the ROTW - probably approaching a userbase of 10 million now - nothing escapes notice: there are no secrets.

Even the health effects of smoking cessation are better reported within this community than anywhere else. Some knowledge acquisition is seen here before anywhere else; for example, the factor-10 difference in individual tolerance to nicotine was reported here first; the effects of nicotine on diabetes and thyroid patients; how smoking cessation symptoms interact with nicotine delivery systems; and even unreported effects of smoking cessation such as possible serious mood-altering effects of cleaning materials; see:
The medical symptoms of smoking cessation

The safety effect

There are many discrete results from this intensive community effect, such as knowledge dispersal, product development pressure and usage contagion. This is a grapevine on steroids, where nothing can be hidden, and nothing stays below the radar for long. But the most important of all is probably the safety aspect: a community looks for discovery and this will impact safety issues as much as anything else.

Some examples:
1. If an incident of any interest occurs in (for example) Germany, it will be reported on the German forums fairly rapidly, and then be seen on the US, UK and international forums very soon thereafter. Nothing remains hidden.

2. A professional chemist within the community who tests product samples at random found that one vendor was supplying bulk materials with very inaccurate nicotine strengths, in some cases with an error of 200%. This news immediately travelled around the e-cigarette forums and within a week the world vaping community knew that this supplier should be avoided.

3. There was a case of pneumonia in a smoker with emphysema and congestive heart disease who became an e-cigarette user. This was wrongly described as lipoid pneumonia by the patient's consultant, who described the refill liquid as 'looking oily'. It turned out he was an anti-tobacco zealot. Incorrect attribution of this nature has subsequently been revealed as propaganda by cardiac consultants, pulmonary consultants and chemists within the community, who all pointed out that this was (a) chemically impossible, (b) emphysema patients commonly develop pneumonia, (c) it would be a unique event among 10 million ecig users in 8 years of experience if lipoid pneumonia could somehow be demonstrated by published pathology (which it was not), and (d) even if it had been factual instead of fabricated, would be of little consequence in any case since if the 10 million current vapers had instead continued to smoke, as many as 5 million would have died.

It is inconceivable that any dangerous product could remain on the market for long. It would both be reported to the authorities and a prosecution would be supported by the community, and it would be shunned in the marketplace so that sales would cease. Something with any safety issues is warned against 100 times more actively by the community than any product can be marketed. Recalls forced by the community are a common occurrence.

It is absolutely inconceivable that any potential for elevated risk can remain unreported, never mind any actual danger. No death attributable to e-cigarette use can be found, from nearly 10 million current users, in almost a decade, and where there have been millions of users for years. Only the rarest cases of morbidity can be located and they are not agreed as attributable to e-cigarette use.

The medical equivalent

Now let's look at the pharmaceutical equivalent in order to compare the relative safety of the products in the real world (rather than in some theoretical regulatory model).

1. There are no user communities for what might be described as the medical equivalents such as nicotine inhalers, gum, skin patches, lozenges and so on, nor for the psychoactive drugs. (Both e-cigarettes and these drugs have roughly the same aim: allowing smokers to avoid tobacco cigarettes.) People use such things under duress; the products are neither pleasant nor attractive to use; and they are designed to be unattractive so that people don't want to use them in the long term. No one is going to be enthusiastic about them; no one is reporting on the issues on a scale sufficient to provide useful information to users or useful warnings to avoid certain products. In practice there is no support or information grapevine.

2. It is also fairly important to realise that much the same thing will apply to e-cigarettes with a pharmaceutical license. It may not be appreciated but the life cycle of most e-cigarette products is about 6 to 9 months: they come onto the market, become popular, and are then replaced by new and better products. The market is so young that technical developments are faster even than those in the world of cellphones.

If something lasts a year or more it is unusual and is normally a case of exceptional engineering in some form. What is used now among the community bears no relation to the products of three years ago, which have mostly been obsolete for two years now. They are regarded as ineffective, low performance, unattractive, expensive in terms of performance vs cost, and just generally old-fashioned and funny. This is a rocket-propelled market area and every year is worth, for example, ten years in the car trade (this analogy makes it easy to understand the issues): there would be very few takers for a 30-year old car model sold as new today and at a higher price than newer, better cars. Who would buy a Morris Minor at £25,000 or an Oldsmobile Cutlass Diesel at $35,000? No one in their right mind. But this is what will be asked of the buyers of licensed e-cigarettes; such products could only be sold in pharmacies since consumers will not buy obsolete, ineffective and overpriced products - why should they?

People are not going to pay $2,000 for a Betamax video recorder today and they won't be enthusiastic about exactly the same deal on an e-cigarette either: an old clunker at double the cost of something modern that works four times as well.

You can immediately see that the minimum 3-year license delay, at about £2m cost, is not going to work well in this market. The first ecig company to apply for a pharmaceutical license more than three years ago still don't have their license. The cost ballooned by a factor of 20, and they still cannot see daylight - even though they probably have the most advanced manufacturing plant in Europe and are supported by local and international university academics from here to Geneva. The product licensing regime is extremely lengthy and extremely costly. It might fly in the medical world but the community will regard a licensed e-cigarette as the Morris Minor of ecigs - too old, too ineffective, and past it. Indeed, the product will have to be used with ultra-high strength nicotine of 45mg/ml (4.5%) because such obsolete models are demonstrated by multiple clinical trials as unsuccessful at delivering nicotine to the blood plasma when used with normal strengths of nicotine refill.

Medical nicotine devices are designed to be unattractive (or they won't get a license); and they are going to be obsolete, ineffective, and of low quality by today's standards (and this applies whenever 'today' is). They will always be 3-year old technology, which is steam age in comparison to the current product line. It's like trying to license a mobile phone but the procedure taking ten years: a pointless waste of time. You would get your license for a clunky old in-car carphone today; but the market has moved on light years to Android phones that you can carry and that work about 100 times better. You then have to charge double the price of an iPhone for your clunky old carphone.

3. Now we should examine a medical product that was introduced at the same time as e-cigarettes and see if they can be compared. Luckily we have a perfect example: Chantix (varenicline) - a smoking-cessation drug that came on the market at the same time, so the timescale is identical, the end result is about the same (no longer using tobacco cigarettes), and we can easily compare their safety profile.

A typical 12-month result success rate established in studies on e-cigarettes so far is 31%, with all factors suboptimal (obsolete hardware, low-strength refills, no mentoring). A similar result for varenicline will be below 10%, even though it is probably the most effective pharmaceutical intervention for smoking cessation. At 20 months, the timepoint used for final determination of smoking status, no pharmaceutical intervention has any independent trial result better than 10% success even with all factors optimal (mentoring is a critical component of all smoking cessation or replacement processes): pharmacotherapies have a 9 out of 10 failure rate for smoking cessation. The first thing we see, then, is that e-cigarettes work much better than pharmacotherapies in helping people avoid smoking.

However the most obvious thing about varenicline is the significant harm it does to the community, and that this harm is unchecked and unstoppable. The FDA report 272 deaths directly attributable to it but expert commentators say this figure is likely to be much higher and most likely over 1,000. This is understandable when the numbers of suicides, murders, and tens of thousands of violent psychotic events and heart attacks it causes are examined. As it is demonstrated in two separate independent clinical studies to have a 1 in 30 risk for a 'cardiac event', it means that just in the USA, just in 2010, Chantix caused more than 60,000 cardiac events.

The FDA have received more than 10,000 serious adverse incident reports for varenicline, compared with 47 for e-cigarettes, in the same time period, and with a larger userbase for e-cigarettes. Prof Rodu examined the ecig-related reports and remarked on the very small number of credible adverse events considering the timescale and the very large userbase.

The key thing to note about varenicline is that apparently it cannot be removed from the market no matter the level of death and destruction it is responsible for. It causes obvious and unnecessary harm, but apparently this is acceptable in medically-licensed products - even if they don't work in the first place, and even if there are solutions that work at least three times better for saving lives, and no matter how many they kill or harm.

To most reasonable people, this licensing regime does not sound perfect. Indeed, it sounds catastrophically harmful. A reasonable person would probably say it is madness to go to this regulatory model when the current one appears perfect.

Consumer products are far safer. The concept that any consumer product could stay on the market with a record like this is plainly ridiculous: people would be in jail.

In addition, the idea that e-cigarettes could cause a fraction of the harm Chantix is responsible for is absolutely inconceivable. Any danger is rapidly exposed and any potentially harmful products are quickly recalled. The consumer product safety authorities take immediate action in the case of a possible threat of a 5 volt shock - something only of any conceivable risk to a goldfish.

The comparative situation is therefore quite clear:
1. Products licensed as medicines can apparently kill and injure without limit.

2. They cannot be removed from the market, no matter the level of death and damage caused.

3. Consumer products are extremely safe in comparison.

4. E-Cigarettes are additionally monitored by an attentive and vocal community.

5. The concept that e-cigarettes could approach even the tiniest fraction of the harm caused by these dangerous licensed products is patently ridiculous.

6. In terms of concrete proof of these points: we already know that e-cigarettes are many thousands of times safer than Chantix. This is irrefutable.

7. We certainly don't want to take a step backward on safety, which it is clear is what medicinal licensing entails. A high death rate and apparently unlimited harm are ignored, and products are protected from removal from the market no matter how ineffective they are and no matter how many deaths they cause.

What will medical licensing for e-cigarettes do?

a. Clearly, it cannot make them any safer or more effective; more likely the reverse.

b. It will make them more dangerous (as they will be outside the community safety net - the community will stay with modern products that work, which will be available on the huge black market that will result from medical licensing).

c. A licensed e-cigarette will clearly be impossible to remove from the market even if it kills hundreds, ruins tens of thousands of lives, or simply doesn't work in the first place.

d. They will only work a fraction as well as modern products (we already know that the first licensed ecig product will be an obsolete and inefficient device that needs rocket fuel in order to even show any drug delivery, and that is a completely separate issue from efficacy).

e. They will automatically have a market restricted by more than 99.999%; but consumer product success depends on a free market with free choice and freedom to innovate.

f. It's a good way to make something more dangerous (which we have just proved), less efficient (as we have just shown), far less attractive (as is fairly clear, since you will agree that fashionable medical devices are in short supply), and far less available (since 99.999% of products will be removed from the market*) - with the result of sales falling through the floor and many less people using them.

The end result is that a very large number of people will die unnecessarily*. This, in reality, goes without saying - as all 'regulatory' moves are in fact designed to protect the status quo (i.e. to protect both cigarette sales and the pharma income from treating sick smokers - two businesses of equal size and profitability).

* However, for the sake of logic, it needs to be pointed out that millions of people will not accept the government and its protected industries attempting to kill them, and will simply go to the black market

Conclusion

The e-cigarette community network is unique. It delivers excellent safety along with other forms of knowledge dispersal. Its power is phenomenal and, because it is entirely new and a product of the digital information age, is neither recognised nor identified; one of its most useful characteristics is that it ensures products are safe.

Of course, this is not something that can be recognised by any form of statutory process; but the question needs to be asked: do we want safe and effective products, with their safety clearly demonstrated and clearly protected by the community - or do we want ineffective and lethally-dangerous products that cause harm on an industrial scale and that are protected by regulation so that they cannot be removed from the market?

The safety record of e-cigarettes is without peer; even aspirin could not approach within a mile of it. Regulation just seems to ensure that products which turn out to be lethally dangerous are protected.


This situation, no matter how incongruous it may seem on first appraisal, has at least been recognised by some:

"I believe the marketplace can do a better job than the government on the issue of public health."
- Jeff Stier, public health expert, The National Center for Public Policy Research, USA [commenting on e-cigarettes]