Rolygate, you are correct that e-cigs are now classed as tobacco products and that tobacco products are not required to show clinical trials. I totally agree with that point. (There are some clinical trials of some tobacco products, but thats a different issue, and your central point is valid). But given that some studies already exist in the literature comparing the effects of e-cigs with those of cigarettes, and these show lower delivery of nicotine and toxins (e.g. CO), and lower physiological effects (e.g. HR) than from cigarettes, why not make their day and submit a dossier making the point that as these products are classed as tobacco products and do not make health claims, the most appropriate clinical study is not a clinical smoking cessation trial but a lab study showing these are less addictive and toxic than cigarettes, and here is what we have so far. However, I think the case against e-cigs also becomes far weaker as soon as there is a decent clinical trial showing that a nicotine-delivering e-cig helps more smokers to quit than a zero nic e-cig and the Nicorette Inhaler. Then reasonable people are going to have to look at that and say, "mmm...far lower toxin delivery than cigarettes, AND seems to help smokers quit better than or as good as an existing approved product (without any signs of serious adverse events)...why are we in a rush to ban such a product?"
Actually the biggest barrier to clinical trials IS and always has been the FDA. The whole reason Ruyan contracted to HealthNZ and not a health organization in America is because Institutional Review Boards can not approve human studies.
See the Joel Nitzkin (Chair of the Tobacco Control Task Force for the American Association of Public Health Physicians)
It literally goes something like this.
Ruyan - We want to sell this product in America
FDA - Well you need to conduct safety testing
Ruyan - Okay, we'll do that
FDA - Well, you can't conduct testing here, our testing guidelines prohibit this
Ruyan - Fine, we'll do it in NZ
FDA - Oh we didn't tell you, it has to be done in America
Ruyan - But we tried that, your guidelines prohibit Institutional Review Boards from approving our research
FDA - We can't permit you to test the product without safety testing in the US, and we can't permit testing in the US
Tobacco Control same situation. The ACS, AHA, ALA, ANSR, made it CLEAR that they will not accept any data sponsored by ANY e-cigarette manufacturer citing the "conspiracy of big tobacco". And I have to concede, they do have a point. But at the same time, they refuse to step up to the plate and sponsor epidemiological studies, clinical trials, or even labs.
So we need a researcher to step up to the plate. First step is actually establishing the nicotine delivery of e-cigarettes.
Jean-Francis Etter is covering this to a degree, but like yourself doesn't quite understand the role watts plays in vapor production. But there might be enough in the way of information from his cotinine tests to establish a relationship. Problem is there is no assurance someone using Type A e-cigarette is using Type A atomizer. I happen to be using a SmokTech manufactured unit, with SmokTech cartomizers, but I could just as easily be using Joytech with Boge.
Next would be epidemiological studies. We have
one from 1996, but this was pure nicotine, not nicotine suspended in a glycol solution. Which is rather why I'm obsessed with watts. You have mg/ml but watts determines ml/sec. I'll have to dig up current data, but I believe there are three currently, LPD Laboratory Services of Blackburn MicroTech Solutions LTD, Bontek Compliance Laboratory Shenzen, China, and Health New Zealand LTD sponsored by Ruyan.
Next would be clinical trials. There are two barriers to that, researchers stepping up to the plate, and the FDA themselves guided by the current administration. As it stands, NRPs are not deployed for long term use, which renders them no better than snake oil. "Some" doctors understand this like Richard Hurt of the Mayo clinic, who outright suggests using them "as long as it takes". To date, as far as I'm aware, this has been limited to Health New Zealand LTD sponsored by Ruyan, Boston University of Public Health, and University of Catania.
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.
This would NRPs and cessation medication like Chantix.
NRPs like the patch are only roughly 10% effective in 12 week programs, falling to 4.3% and lower after 24 weeks. 8-11 cessation attempts are required, where 14% of the population continues to smoke until death. They are more effective outside of 12 week programs, and the FDA is researching approving them as such. NRPs and counseling are a good deal more effective.
I don't have accurate figures on Chantix, however what it is, 72% increased risk of heart attack, 35,000 adverse reactions, 10,000 serious or even fatal? 5 million users and how many murder and suicides?
E-cigarettes have been on the market an equal period of time. To justify their place on the market place, they only need to be between 75-80% less harmful than cigarettes. That is in simple terms, .20%-.25% of their user base of 2.5 million dropping dead every year, vs. cigarettes 1% based on CDC figures. This would be worst case scenario, total adoption by 100% of the population, representing equal harm. The current estimates are in excess of 99%, where even the FDA conceded in court that there is no evidence they harmed anyone, as opposed to Chantix.
But instead of sponsoring further research, the FDA is backing the
flaming cessation device. $2.5 million dollars to study the role low nicotine cigarettes play in cessation.
