Ande, I understand your point, and Im sure what you describe is the real life experience of many who persisted and successfully quit smoking using e-cigs. But if someone was trying to design a clinical trial to test if these things really do help smokers quit, or to identify which ones are most helpful, they cannot just send people on a journey of exploration. We need to pick the model that has the best chance right from the start, so it really has a shot at doing better than the alternative (e.g. better than the FDA approved nicotine inhaler for example). As many have pointed out, these studies are expensive, time-consuming, and if the first couple choose the wrong e-cigs and find they dont work then that might be the end of that. Similarly, although I am pleased for those who are persistent and intelligent enough to go online, get advice, figure out the ohms and watts etc, and eventually succeed in quitting smoking with e-cigs, I wonder how many tried the poor version, found it was neat but didnt really hit the spot, and went back to their Marlboros? What is the cost of having most people start on inferior products?
E-Cigarette Clinical Trials
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Each argument is correct. However if you want to trial e-cigarettes, it's very much like trialling desserts. One you like, I'll hate, and vice-versa. A trial of one dessert would conclude that very few people like them.
What won't be mentioned by anyone using the data, a lot further on down the road, is that very few subjects would actually prefer tiramisu with custard, which is what you gave them. Some prefer ice cream, some apple pie, some want it with cream, some with custard. Some want it hot, some want it cold. A trial of cold tiramisu with hot custard is not a trial of desserts - 90% may not like it, and go back to candy bars.
E-cigarettes offer a huge range of options, with different types, and different models within those types; different types of refill (PG, VG, etc); different flavors; and different nicotine strengths. That's why they work. There is a variety of options, something to suit everyone. A single option suits 5% of people or whatever. The rest would go back to smoking.
If the trial is locked to one model, then you have to accept that a good percentage will fail to stay with it as the model is not suitable for them. This has to be fully explained in the conclusions: "We would expect to achieve an additional 40% success rate if we offered a full range of equipment". Any other conclusion is a misrepresentation. In effect you are trialling cheese and biscuits, if that's what you offer - not desserts. You can't answer the question, "Do people like desserts?" if you only offer them cheese and biscuits.
And at the very least, you have to offer a full range of flavors and a full range of nicotine strengths - or it won't work at all. We already know what percentage succeed when given one option of hardware: 31%. Give them a proper range, and we get 80%, anecdotally. The difference is so large that it renders a restricted test virtually meaningless. You will get results of the same type as Eissenberg 1 - i.e. laughable and meaningless.
If you want to trial e-cigarettes then that is what you should do. Don't give cigarette smokers a cigar, or vice-versa. The results won't be worth the paper they are written on.
The problem is, researchers seem to think there is some sort of parallel between tobacco cigarettes and electronic cigarettes. There isn't - every single aspect is different. The funniest results of all are obtained by researchers testing the vapor: every photo of their lab set-ups show them using the e-cig upside down, as that was how they tested cigarettes. E-cigs don't work like that. A cigarette might, but an e-cigarette is not a tobacco cigarette. An e-cig works about as well upside down as your electric kettle would, as it's a gravity-fed liquid-feed device. Thus the 'vapor' result is shown to include smoke from melting plastics...
Researchers have a big problem - they need to fit their methodology to the subject under test - not the other way round. Please try to learn from previous mistakes, there is no point in repeating them.
You could certainly run a meaningful trial using 4 different models, as these would suit most people. The question is: over what timeframe? Over 1 month and you'll be laughing. Over a year, and with one model only, you'll get about a 70% failure rate. We already know this. Look, here is the vaper's progress:
Day 1: 95% must have something that looks just like a cigarette and preferably tastes like one as well. They will give up within a week if given an eGo or Riva or something even bigger. They just want a cigarette replacement - and nothing else will do. Preferably an auto model.
Day 30: At least half have got sick of the short battery life and pathetic vapor offered by their mini, and want something better. They get a large-format like an eGo or Riva. They won't accept a large mod or a boxmod. Some will accept a manual model now.
Day 90: almost all have moved up to a large-format or mod. Manual is pretty much standard, they've realized that auto models are for noobs. Almost everyone has two different models, for different times of the day and so on.
Day 180: 75% are using a large-format or a mod. They are very, very picky about what they will or won't use. Just like you won't wear your wife's pink shirt and she won't wear your oily jeans you fix the car with. Hardly surprising - chacun à son goût. Everyone has several different models by now (I've never heard of anyone @6m with one e-cig - it just doesn't exist).
Day 360: Most now use a large-format or a big tube mod, or a boxmod, and with a tank or a carto or a dripper atty (there is no kind of conformity). In other words, most would have dropped out if only a mini was available. And over 50% would also have dropped out if only a large-format was available, as they preferred a mod or a mini.
Some use 0 nic, some 18mg, some 36mg, a few even use 48mg or 54mg, which has to be DIY'ed as you can't buy it easily. Some use DIY WTA liquid as it's hard to buy. There is no conformity.
Some use 5% mild flavors, some use 15% average flavor, some use 25% of chilli extract that would rip your throat out. There is no conformity.
Oh, and people have a selection of models to choose from now. Some have 50 or more, all have at least three, and the latter are modern-day Scrooges.
A trial of e-cigarettes needs to be just that. In contrast, a trial of an eGo or a Riva (both are 'large-format' e-cigs) is just that: a trial of an eGo. It certainly isn't a trial of e-cigarettes, and it would be a misrepresentation to call it such. I think we have all had enough of misrepresentation.
Please don't get sucked into the junk science department, e-cigarettes are a major trap for the unwary and many have fallen in. You cannot later on say you didn't realise, after all. Tom E. had to start again from the beginning, to the sound of riotous laughter - but you have had advance warning.
What won't be mentioned by anyone using the data, a lot further on down the road, is that very few subjects would actually prefer tiramisu with custard, which is what you gave them. Some prefer ice cream, some apple pie, some want it with cream, some with custard. Some want it hot, some want it cold. A trial of cold tiramisu with hot custard is not a trial of desserts - 90% may not like it, and go back to candy bars.
E-cigarettes offer a huge range of options, with different types, and different models within those types; different types of refill (PG, VG, etc); different flavors; and different nicotine strengths. That's why they work. There is a variety of options, something to suit everyone. A single option suits 5% of people or whatever. The rest would go back to smoking.
If the trial is locked to one model, then you have to accept that a good percentage will fail to stay with it as the model is not suitable for them. This has to be fully explained in the conclusions: "We would expect to achieve an additional 40% success rate if we offered a full range of equipment". Any other conclusion is a misrepresentation. In effect you are trialling cheese and biscuits, if that's what you offer - not desserts. You can't answer the question, "Do people like desserts?" if you only offer them cheese and biscuits.
And at the very least, you have to offer a full range of flavors and a full range of nicotine strengths - or it won't work at all. We already know what percentage succeed when given one option of hardware: 31%. Give them a proper range, and we get 80%, anecdotally. The difference is so large that it renders a restricted test virtually meaningless. You will get results of the same type as Eissenberg 1 - i.e. laughable and meaningless.
If you want to trial e-cigarettes then that is what you should do. Don't give cigarette smokers a cigar, or vice-versa. The results won't be worth the paper they are written on.
The problem is, researchers seem to think there is some sort of parallel between tobacco cigarettes and electronic cigarettes. There isn't - every single aspect is different. The funniest results of all are obtained by researchers testing the vapor: every photo of their lab set-ups show them using the e-cig upside down, as that was how they tested cigarettes. E-cigs don't work like that. A cigarette might, but an e-cigarette is not a tobacco cigarette. An e-cig works about as well upside down as your electric kettle would, as it's a gravity-fed liquid-feed device. Thus the 'vapor' result is shown to include smoke from melting plastics...
Researchers have a big problem - they need to fit their methodology to the subject under test - not the other way round. Please try to learn from previous mistakes, there is no point in repeating them.
You could certainly run a meaningful trial using 4 different models, as these would suit most people. The question is: over what timeframe? Over 1 month and you'll be laughing. Over a year, and with one model only, you'll get about a 70% failure rate. We already know this. Look, here is the vaper's progress:
Day 1: 95% must have something that looks just like a cigarette and preferably tastes like one as well. They will give up within a week if given an eGo or Riva or something even bigger. They just want a cigarette replacement - and nothing else will do. Preferably an auto model.
Day 30: At least half have got sick of the short battery life and pathetic vapor offered by their mini, and want something better. They get a large-format like an eGo or Riva. They won't accept a large mod or a boxmod. Some will accept a manual model now.
Day 90: almost all have moved up to a large-format or mod. Manual is pretty much standard, they've realized that auto models are for noobs. Almost everyone has two different models, for different times of the day and so on.
Day 180: 75% are using a large-format or a mod. They are very, very picky about what they will or won't use. Just like you won't wear your wife's pink shirt and she won't wear your oily jeans you fix the car with. Hardly surprising - chacun à son goût. Everyone has several different models by now (I've never heard of anyone @6m with one e-cig - it just doesn't exist).
Day 360: Most now use a large-format or a big tube mod, or a boxmod, and with a tank or a carto or a dripper atty (there is no kind of conformity). In other words, most would have dropped out if only a mini was available. And over 50% would also have dropped out if only a large-format was available, as they preferred a mod or a mini.
Some use 0 nic, some 18mg, some 36mg, a few even use 48mg or 54mg, which has to be DIY'ed as you can't buy it easily. Some use DIY WTA liquid as it's hard to buy. There is no conformity.
Some use 5% mild flavors, some use 15% average flavor, some use 25% of chilli extract that would rip your throat out. There is no conformity.
Oh, and people have a selection of models to choose from now. Some have 50 or more, all have at least three, and the latter are modern-day Scrooges.
A trial of e-cigarettes needs to be just that. In contrast, a trial of an eGo or a Riva (both are 'large-format' e-cigs) is just that: a trial of an eGo. It certainly isn't a trial of e-cigarettes, and it would be a misrepresentation to call it such. I think we have all had enough of misrepresentation.
Please don't get sucked into the junk science department, e-cigarettes are a major trap for the unwary and many have fallen in. You cannot later on say you didn't realise, after all. Tom E. had to start again from the beginning, to the sound of riotous laughter - but you have had advance warning.
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I see what you're saying- but the problem is, the initial products are not (always, merely) inferior. They're different.
I wanted a small battery to begin with because A) it felt more comfortable, as I was a cigarette smoker, and B) I had no idea about the advantages of bigger batteries.
It was a necessary step.
By saying "we need to choose ONE model" what you're saying is: "We have to test to see if ecigarettes work in exactly the way they aren't really used."
Like Rolygate, I know no long term ecig users who own only one model.
I can speak only for myself on this: If the one I'm using now (Apex Alpha Ultramax) were the only one available to me, I never would have started vaping. (Too expensive up front, too weird looking, too much learning curve.) But if the one I started with were the only one available, I might have given up. (Too short battery life, no durability at all, too expensive in the long term.)
If you want to study the effectiveness of ecigs in general, you can't do it by studying one model. There is no one size fits all.
There are ways to study the phenomenon as a whole, but most don't fit into the "clinical trials" framework.
Best,
Ande
Darn Roly, that was an amazing description of the progression that takes place and the time frames, at least those willing to spend the internet time to learn what they don't know. I worked my way up on your described progression to a Chuck which I loved for the longest time using 510 atomizers. I read about all the LR stuff and cartomizers and clearomizers, but by 510 atty was just fine.
Then I went reverse direction to a product that had been around for a long time and is really "old fashioned" by today's standards of variable voltage yada, yada. I picked up the famous Screwdriver with a 510 tank atty and it's perfect, for me. Feels great in my hand, almost held "pipe" like. A ml of WTA lasts me about 3 days, I recharge the battery every few days, no extra supplies to carry. All in all a lot cheaper than smoking, a lot tastier than smoking, and a lot easier than carrying around 3 packs of cigarettes every day to feed my former 43 year habit.
Jf, trying to put these things in a clinical trial setting is noble, but they really aren't a smoking cessation product. They're a commercial alternative to smoking that just happens to make it easier for a lot of folks to stop smoking. Even when their original intended use of the product had nothing to do with smoking cessation. These words are written by a confirmed smoker turned confirmed ex-smoker.
Then I went reverse direction to a product that had been around for a long time and is really "old fashioned" by today's standards of variable voltage yada, yada. I picked up the famous Screwdriver with a 510 tank atty and it's perfect, for me. Feels great in my hand, almost held "pipe" like. A ml of WTA lasts me about 3 days, I recharge the battery every few days, no extra supplies to carry. All in all a lot cheaper than smoking, a lot tastier than smoking, and a lot easier than carrying around 3 packs of cigarettes every day to feed my former 43 year habit.
Jf, trying to put these things in a clinical trial setting is noble, but they really aren't a smoking cessation product. They're a commercial alternative to smoking that just happens to make it easier for a lot of folks to stop smoking. Even when their original intended use of the product had nothing to do with smoking cessation. These words are written by a confirmed smoker turned confirmed ex-smoker.
That sums it up quite well. Falling back on the technical details, a former pack/day smoker will need at least 650mAh to 1100mAh @ 3.7V/day (2.405W/hrs-4.07W/hrs). This represents 481-814 4watt 4.5second drags.
This means 5 mini (~AAAA) sized batteries/day, or 10 super-minis. Given li-ion technology is limited to 300 charge cycles/battery, this means 1 battery every 60 days for a mini, one battery every 30 days for a super mini.
The smallest practical battery to deliver 666 drags over a period of 16 hours happens to be a 3.7V AA (14500), where a 13450 (base Ego Style) will cover 480 drags, 13650 will cover 815 drags, where a drag is defined as 4.5 seconds at 4 watts.
Matt, never thought about the science of battery drain until your post but it does explain why I carried a handful of 510 batteries in the beginning and a 900 mAh lasts me a few days. I don't take nearly the number of puffs a day on my E cig as I did when I started and nothing close to the number of drags.
My concern is that when FDA gets round to regulating e-cigs, the way they do it may depend on whether the available evidence suggests that these things are (a) probably harmful (b) an unhelpful but almost harmless side show or (c) potentially very helpful in getting smokers to quit, with only minor risks. (Obviously there are many more permutations but you get the idea). Where they start from may depend on how that picture looks. If we have a couple of cases of child poisonings, many consumer reports of batteries on fire, liquid leaks, burned throats, and no solid evidence that they really help people quit, then you know where that is headed. If, on the other hand we have a couple of clinical trials showing that these things may be more effective for smoking cessation than current meds, AND dont appear to cause any more concerning side effects/adverse events than existing products AND the leading manufacurers out there appear to be behaving in a responsible manner, then they may not come down hard and may give manufacturers more time to bring themselves up to snuff. Now that legal rulings suggest that e-cigs can be regulated as tobacco products, when FDA picks that up and decides to exert jurisdiction, they can REQUIRE ALL retailers to provide a ton of data about the products. I dont think most of the companies are ready to deal with that (lots of small ones as you have suggested). The most likely scenario will be some consolidation, maybe some takeovers by pharma or tobacco companies, with most retailers going out of business because they arnt set up to comply. Small home-made producers will obviously continue and there will be an underground network, but the business as we know it will likely change, if it exists at all. Regardless of the rights and wrongs, this is a likely scenario, and how good or bad it is will largely depend on what the scientific evidence suggests about how helpful or harmful these products are. Scientific evidence does not mean how many people say online they were helpful or how many long and winding journeys were taken. It will mean lab studies of emissions, lab studies of nicotine and toxicants absorbed, and standard randomized clinical trials showing the short and long term effects of these products. No-one is going to do lab studies and clinical trials on 150 products...they will have to decide on the best products that are likely to be around for a while and widely used. Hence my questions.
...or to quote a member of this forum...
"Don't waste your money on anything even close to the size of a cigarette. They don't hit hard, and don't hold a charge."
"Don't waste your money on anything even close to the size of a cigarette. They don't hit hard, and don't hold a charge."
If you know the mAh, the mean voltage, and the number of batteries, you've got watt hours
If you know the power consumption in watts, you've got vapor density.
Know the nicotine concentration, and daily use in ML, you can break it down to
1) Nicotine per average puff
2) the amount of other materials per puff
Basically quantized data to toss to epidemiology, with a margin of error of +/-10%, the standard variance of any resistor on a circuit.
I believe that a true trial of e-cigarettes could be reduced to 4 models. There are 5 ranges but to reduce costs and management issues, 4 models could be used.
1. The mini range - models include the KR808 and 510. The KR8 is the natural choice as it is the lowest hassle option, which is important for new users. All 'starters' could be given this model. This is 1st-generation equipment.
2. The large-format range - eGo, Riva, Tornado. A Riva is the best choice as it combines economy with a slightly higher voltage than the other two. Subjects could be offered this at Day 15. This is 2nd-generation hardware.
3. The 3.7 volt mod - Silver Bullet etc. If you are going to use a 3.7v option, there is no point in using the lower-performing 14500 cells, you need to offer the 18650 cell option, as these can deliver full power (no voltage drop). The whole point of this option is to deliver a 4-volt vape, so an 18650 cell has to be used (smaller cells will drop under load). A cheap 18650 mod can be found. This is 2nd-generation hardware.
4. The 5 volt mod with regulator - this is 3rd-gen gear. A cheap boxmod can be used.
5. The V.V. mod range - 3rd-gen gear. Variable voltage mods are expensive and trial subjects can make do with one of the previous 4 options.
The result would be a trial of e-cigarettes. I appreciate the issues surrounding this question but a trial of a Riva or eGo is just that, a trial of a Riva. The overall success rate would be lower than that achieved with a more complete range of hardware. It depends what you want to achieve. I think that the success rate would be higher than the 31% reported as the success rate in a survey of single option / mini users - but nowhere near the 75% or 80% we would hope to achieve with a full range of hardware and refills, plus full mentoring. It might reach 50 - 60% for example. In the end the determinant might be the amount of mentoring support, it seems to be generally agreed that this is an important factor in these programmes.
Certainly, if we gave 10 people some gear and told them to get on with it, and another 10 the same gear and mentored them, at 6 months there would be a significantly higher success rate within the mentored group.
To do the job properly also requires the the use of WTAs in some shape or form.
1. The mini range - models include the KR808 and 510. The KR8 is the natural choice as it is the lowest hassle option, which is important for new users. All 'starters' could be given this model. This is 1st-generation equipment.
2. The large-format range - eGo, Riva, Tornado. A Riva is the best choice as it combines economy with a slightly higher voltage than the other two. Subjects could be offered this at Day 15. This is 2nd-generation hardware.
3. The 3.7 volt mod - Silver Bullet etc. If you are going to use a 3.7v option, there is no point in using the lower-performing 14500 cells, you need to offer the 18650 cell option, as these can deliver full power (no voltage drop). The whole point of this option is to deliver a 4-volt vape, so an 18650 cell has to be used (smaller cells will drop under load). A cheap 18650 mod can be found. This is 2nd-generation hardware.
4. The 5 volt mod with regulator - this is 3rd-gen gear. A cheap boxmod can be used.
5. The V.V. mod range - 3rd-gen gear. Variable voltage mods are expensive and trial subjects can make do with one of the previous 4 options.
The result would be a trial of e-cigarettes. I appreciate the issues surrounding this question but a trial of a Riva or eGo is just that, a trial of a Riva. The overall success rate would be lower than that achieved with a more complete range of hardware. It depends what you want to achieve. I think that the success rate would be higher than the 31% reported as the success rate in a survey of single option / mini users - but nowhere near the 75% or 80% we would hope to achieve with a full range of hardware and refills, plus full mentoring. It might reach 50 - 60% for example. In the end the determinant might be the amount of mentoring support, it seems to be generally agreed that this is an important factor in these programmes.
Certainly, if we gave 10 people some gear and told them to get on with it, and another 10 the same gear and mentored them, at 6 months there would be a significantly higher success rate within the mentored group.
To do the job properly also requires the the use of WTAs in some shape or form.
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Rating vaporizers in terms of Wattage (power) is probably the most accurate measurement as the amount of liquid that can be vaporized by a given amount of power is a fairly straightforward calculation. If, say, an 1000W fog machine uses 1L per hour of operation (finding the exact number is a good exercise for the reader), we could predict that an 10Watt e-cig (5V@2.5ohm or 4.2V@1.8ohm) would use about 10ml (approx 2 teaspoons) per hour of continuous operation, replacing approximately 60 cigarettes at 12x5sec puffs/cig. The fact that it is common for a 3PAD smoker to use upwards of 10ml/day, bears out this theory.
This is why nicotine delivery measured from e-cigs, in trials conducted thus far, because the power output of most batteries is not linear--thus the reason many experienced vapers prefer larger batteries for a more consistent vape since the voltage curve is not as steep on a 1000mAH eGo as it is on a 180mAH 510 battery.
For these reasons, I predict that a regulated power device like the Darwin or mods "Kicked by Evolv" would be best suited for use in a clinical trial. If doctors and researchers are concerned with e-cigarettes ability to deliver a consistent amount of nicotine, they should give smokers who have been unable or unwilling to quit smoking a prescription for a power regulated e-cig.
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- Apr 2, 2009
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I'm pleased JF has identified himself, and I'm pleased that he's continuing to participate in this discussion.
While clinical trials are appropriate (and necessary) for manufacturers and importers of therapeutic drugs and devices, there are no incentives (nor rationale) for manufacturers or importers of e-cigarettes, dissolvables, snus, or other smokeless tobacco products to conduct an expensive smoking cessation clinical trial for any those smokefree tobacco products (at least in the US).
Besides, as others have stated, e-cigarette prohibitionists would respond to any clinical trial (just as Stan Glantz did to Riccardo Polosa's study) by claiming that any study funded by an e-cigarette company cannot be trusted, and that independent research is necessary.
Back in 2008, I privately asked many different tobacco control and smoking cessation researchers, health organizations, foundations, and public health agencies to conduct scientific studies (including clinical trials) on e-cigarettes and/or e-cigarette consumers.
Unfortunately for public health, scientific inquiry and objectivity, the responses by many/most of those entities was instead to issue press releases and propaganda that falsely accused all e-cigarette companies of target marketing to children, that falsely accused all e-cigarette companies of marketing their products for therapeutic purposes, and that called for prohibition of e-cigarette sales (which of course was deceitfully referred to as FDA regulation of e-cigarettes).
Although the FDA conducted a laboratory study of e-cigarette samples from SE and NJOY in the spring of 2009, then FDA Deputy Commissioner Josh Sharfstein (who has vehemently opposed tobacco harm reduction since 2005 when he worked for Henry Waxman to lobby Congress to enact the FSPTCA, and to oppose every harm reduction amendment I advocated to improve the bill) held a press conference that grossly misrepresented the FDA 's laboratory findings, that fasely accused e-cig companies of marketing to youth, and that falsely claimed all e-cig companies made therapeutic claims about their products.
Since then, I (and many other objective people) have informed many officials and staff at FDA many times about the agency's lies and misrepresentations about e-cigarettes. But to this day, the FDA has refused to correct/clarify/retract any of its lies and misrepresentations about e-cigarettes, and has refused to correct or clarify any of the thousands of other lies and/or gross misrepresentations about e-cigarettes that have appeared or been repeated in the news media, in peer reviewed journal articles, and by other e-cigarette prohibitionists. Instead, the FDA has chosen to continue posting its lies and misrepresentations about e-cigarettes on its website, which has encouraged many more people to repeat and further exaggerate the FDA's lies and misrepresentations.
Besides, the FDA has already stated (on April 25 when conceding to Judge Leon's ruling that e-cigs are tobacco products) at Regulation of E-Cigarettes and Other Tobacco Products
The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
Therefore, it appears that e-cigarette prohibition continues to be the FDA's unwritten policy for e-cigarettes, as Section 910 of the FSPTCA could/would ban all e-cigarette products that weren't on the market prior to February 15, 2007 (which is virtully all e-cigarette products now on the market).
The FDA also has lied and grossly misrepresented the scientific and empirical evidence about the known health risks and benefits of all noncombustable tobacco products.
For example at Health Fraud
the FDA fraudulantly claims (on a webpage entitled Health Fraud)
Tobacco-Related Health Fraud
All tobacco products are harmful to your health, despite what they taste, smell, or look like. Claiming less harm or reduced risk of disease from using tobacco products misleads consumers to think that these products are safe to use. FDA considers these kinds of claims to be health fraud. These kinds of claims can only be made after scientific evidence to support them has been submitted to FDA, and FDA has issued an order permitting their marketing use. To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products.
My point is that FDA needs to retract/correct/clarify the agency's many lies and misleading claims about e-cigarettes (and other far less hazardous noncombustable tobacco alternatives to cigarettes), and needs to end its abstinence-only prohibitionist policies towards smokefree alternatives before the agency can be trusted to evaluate or communicate scientific evidence about smokefree tobacco products.
The only way I can envision the FDA doing this and regaining the trust of tobacco harm reduction advocates (including e-cigarette companies and customers) during the next several years is if Obama is defeated by a Republican in next year's election.
While clinical trials are appropriate (and necessary) for manufacturers and importers of therapeutic drugs and devices, there are no incentives (nor rationale) for manufacturers or importers of e-cigarettes, dissolvables, snus, or other smokeless tobacco products to conduct an expensive smoking cessation clinical trial for any those smokefree tobacco products (at least in the US).
Besides, as others have stated, e-cigarette prohibitionists would respond to any clinical trial (just as Stan Glantz did to Riccardo Polosa's study) by claiming that any study funded by an e-cigarette company cannot be trusted, and that independent research is necessary.
Back in 2008, I privately asked many different tobacco control and smoking cessation researchers, health organizations, foundations, and public health agencies to conduct scientific studies (including clinical trials) on e-cigarettes and/or e-cigarette consumers.
Unfortunately for public health, scientific inquiry and objectivity, the responses by many/most of those entities was instead to issue press releases and propaganda that falsely accused all e-cigarette companies of target marketing to children, that falsely accused all e-cigarette companies of marketing their products for therapeutic purposes, and that called for prohibition of e-cigarette sales (which of course was deceitfully referred to as FDA regulation of e-cigarettes).
Although the FDA conducted a laboratory study of e-cigarette samples from SE and NJOY in the spring of 2009, then FDA Deputy Commissioner Josh Sharfstein (who has vehemently opposed tobacco harm reduction since 2005 when he worked for Henry Waxman to lobby Congress to enact the FSPTCA, and to oppose every harm reduction amendment I advocated to improve the bill) held a press conference that grossly misrepresented the FDA 's laboratory findings, that fasely accused e-cig companies of marketing to youth, and that falsely claimed all e-cig companies made therapeutic claims about their products.
Since then, I (and many other objective people) have informed many officials and staff at FDA many times about the agency's lies and misrepresentations about e-cigarettes. But to this day, the FDA has refused to correct/clarify/retract any of its lies and misrepresentations about e-cigarettes, and has refused to correct or clarify any of the thousands of other lies and/or gross misrepresentations about e-cigarettes that have appeared or been repeated in the news media, in peer reviewed journal articles, and by other e-cigarette prohibitionists. Instead, the FDA has chosen to continue posting its lies and misrepresentations about e-cigarettes on its website, which has encouraged many more people to repeat and further exaggerate the FDA's lies and misrepresentations.
Besides, the FDA has already stated (on April 25 when conceding to Judge Leon's ruling that e-cigs are tobacco products) at Regulation of E-Cigarettes and Other Tobacco Products
The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
Therefore, it appears that e-cigarette prohibition continues to be the FDA's unwritten policy for e-cigarettes, as Section 910 of the FSPTCA could/would ban all e-cigarette products that weren't on the market prior to February 15, 2007 (which is virtully all e-cigarette products now on the market).
The FDA also has lied and grossly misrepresented the scientific and empirical evidence about the known health risks and benefits of all noncombustable tobacco products.
For example at Health Fraud
the FDA fraudulantly claims (on a webpage entitled Health Fraud)
Tobacco-Related Health Fraud
All tobacco products are harmful to your health, despite what they taste, smell, or look like. Claiming less harm or reduced risk of disease from using tobacco products misleads consumers to think that these products are safe to use. FDA considers these kinds of claims to be health fraud. These kinds of claims can only be made after scientific evidence to support them has been submitted to FDA, and FDA has issued an order permitting their marketing use. To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products.
My point is that FDA needs to retract/correct/clarify the agency's many lies and misleading claims about e-cigarettes (and other far less hazardous noncombustable tobacco alternatives to cigarettes), and needs to end its abstinence-only prohibitionist policies towards smokefree alternatives before the agency can be trusted to evaluate or communicate scientific evidence about smokefree tobacco products.
The only way I can envision the FDA doing this and regaining the trust of tobacco harm reduction advocates (including e-cigarette companies and customers) during the next several years is if Obama is defeated by a Republican in next year's election.
For these reasons, I predict that a regulated power device like the Darwin or mods "Kicked by Evolv" would be best suited for use in a clinical trial. If doctors and researchers are concerned with e-cigarettes ability to deliver a consistent amount of nicotine, they should give smokers who have been unable or unwilling to quit smoking a prescription for a power regulated e-cig.
Actually the 2nd generation KR808D-1s would likely be a good candidate. They're 5V batteries regulated to 3.7V, in 220mAh and 320mAh. These would give a wider margin of error since no one in their right mind would go to bed without charging up their weakest battery, vs the ego which you could ignore overnight and track battery charges a week, month, or longer.
The Joye ego should qualify as it's capped to the discharge voltage of a 13450-13750. At 2.5ohms it's going to output 4watts from start to finish. If nothing else, it'll confuse our observer, jfjardine02, as technically speaking the Joye Ego is less able to deliver vapor than a gas station e-cig.
Bill, 3 comments:
1. I may be wrong, but I suspect that FDA staff may be more open to considering your comments if you didn't start off by accusing them of being liars. In fact probably anyone is more open to considering a comment if the person making it doesnt accuse them of some wrong-doing in the same breath. Just a thought.
2. You say there are no incentives to do proper research like controlled clinical trials. I'm suggesting that it may be the difference between staying in business or not. At the very least it is the difference between marketing something on the level of snake-oil and marketing something that has been demonstrated to do something useful without harming people. If this market continues to exist it will become more competitive. The first company that can produce serious evidence that their product is safe and effective will have an advantage....particularly if the data show that it is safer and more effective than competitors. It is better that research be conducted independently, but ultimately any solid research is better than the current near vaccum.
3. That last sentence you wrote was a real bazinga moment. Apart from these issues not having a lot to do with party politics, if you think that any Republican President will be a bigger friend to serious tobacco harm reduction than a President who just practiced it himself, I think you are mistaken. But please...lets not get onto some political tirade about Obama or any other party politics...it is not what this thread is about.
1. I may be wrong, but I suspect that FDA staff may be more open to considering your comments if you didn't start off by accusing them of being liars. In fact probably anyone is more open to considering a comment if the person making it doesnt accuse them of some wrong-doing in the same breath. Just a thought.
2. You say there are no incentives to do proper research like controlled clinical trials. I'm suggesting that it may be the difference between staying in business or not. At the very least it is the difference between marketing something on the level of snake-oil and marketing something that has been demonstrated to do something useful without harming people. If this market continues to exist it will become more competitive. The first company that can produce serious evidence that their product is safe and effective will have an advantage....particularly if the data show that it is safer and more effective than competitors. It is better that research be conducted independently, but ultimately any solid research is better than the current near vaccum.
3. That last sentence you wrote was a real bazinga moment. Apart from these issues not having a lot to do with party politics, if you think that any Republican President will be a bigger friend to serious tobacco harm reduction than a President who just practiced it himself, I think you are mistaken. But please...lets not get onto some political tirade about Obama or any other party politics...it is not what this thread is about.
Mattzuke, "technically speaking the Joye Ego is less able to deliver vapor than a gas station e-cig"
Could you explain?...in language for a 5th grader?
Could you explain?...in language for a 5th grader?
This has the potential to get very interesting.
First off, jfjardine02, you should understand that you are talking to a bunch of people who have long since been convinced that the FDA is bought and paid for by our direct competition, which is Big Pharma. We know who butters their bread. We have seen over and over again the disdain that the FDA holds for electronic cigarettes. We have witnessed their attempts to ban them. We watched as they purposely and purposefully initiated a publicity campaign of distortion, fear, and deception against electronic cigarettes. We think we understand their motivations and intentions full well by this time.
First off, jfjardine02, you should understand that you are talking to a bunch of people who have long since been convinced that the FDA is bought and paid for by our direct competition, which is Big Pharma. We know who butters their bread. We have seen over and over again the disdain that the FDA holds for electronic cigarettes. We have witnessed their attempts to ban them. We watched as they purposely and purposefully initiated a publicity campaign of distortion, fear, and deception against electronic cigarettes. We think we understand their motivations and intentions full well by this time.
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I skipped the 5th grade.
The short answer. A Joye Ego, unlike the Riva 510, is capped at 3.2V. This is 1/2 volt less than a typical gas station e-cig. Less volts at the same resistance = less power. Further off the charger, a gas station e-cig, and the Riva 510, will be 1/2 volt higher than 3.7. More volts at the same resistance = more power.
Even if the Joye ego ships with a 2.5 ohm, and the gas station e-cig ships with a 3.5ohm, the right resistance for 4 watts on either or, the gas station e-cig, and the Riva 510, will have more of a kick fresh off the charger, mellow out, and fade away.
See chart
ohms---3.7v--- --3.2v--
3.5 ohm 4 watt 3watt
3.0 ohm 4.5 watt 3.5 watt
2.5 ohm 5.5 watt 4 watt
2.0 ohm 6.8 watt 5.12 watt
1.7 ohm 8 watt 6 watt
1.5 ohm 9 watt 6.8 watt
For laughs I was using my gas station e-cig (KR808D-1 with adapter) with both a 1.5 and 1.7 ohm, and on my T-rex, which is like a Joye Ego, 3.2V. It produced more vapor for about 40 drags, and faded really fast. This is not practical, and it's not designed for this much power.
Experience has taught us otherwise. Gabbi Promoff (CDC Office on Smoking and Health - gabbi.promoff@cdc.hhs.gov) co-wrote a "Research Paper" on ENDS with quite a bit of erroneous data. Gregory Conley contacted her and explained she should actually read the actual FDA report. I took it upon myself to send her a copy, attempted to correct some errors.
"; however, preliminary studies have observed the presence
of glycerin (non toxic), genotoxins (not cited), known carcinogens(no more than the patch) (13) and diethylene glycol (at food grade levels earlier that year)(14) "
Myself to Gabbi said:
It seems she was confused, my giving her what she was apparently asking for must have suggested I was in Tobacco Control, and asked me to fact check her publication. "I apologize for my previous email. I am looking into this matter and will get back to you." This was November 3rd. No retraction offered despite giving her the primary source.
This is tobacco control, whole research papers written based on tertiary resources, and the status quo.
We just need a researcher to step up to the plate. Tobacco control will obviously not accept a clinical study funded by the industry, even if their support is in the form of just equipment. And it's hardly a near vacuum.
Again, Master's Settlement, but no one in Tobacco Control is stepping up to the plate. There's a logical reason for this, e-cigarettes are inconsistent with denormalization efforts. Organizations like the ALA, AHA, Non-smokers rights and others literally say it's the e-cigarette industry's responsibly to fund research. When Ruyan did though HealthNZ, they ignored it claiming "well that was sponsored by the e-cigarette industry. There really is a game of shifting the burden of proof, then moving the goalposts.
This IS the domain of Tobacco Control, but to date, no one has seen fit to allocate dime one, with the exception of Prue Talbot's grant to study YT videos, and the affect vapor has on stem cells.
Meanwhile, the same standard of evidence you claim is vacuous is what allowed Chantix to go on the market. Chantix is the exception, but there is a lot more evidence on it's relative ineffectiveness than there is on e-cigs, cold turkey, or NRPs and counseling.
So we do need a researcher to step up to the plate. The "industry" in China does recognize the value. But to be accepted, no funds or equipment can be accepted from the "industry".
This isn't paranoia. It's the Obama administration that proposed the e-cigarette ban on flights, and it was a Democratic bill that proposes taxing e-cigarettes exactly the same as cigarettes, I believe for a total of 4x as expensive. It is the present democratic position, strong tobacco control, no harm reduction.
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