FDA Please keep up the FDA comments everybody!

[dragonpuff]

I think I get it. Why, is there going to be a pop quiz?

Imagine that someone who works at the FDA is reading your comment. Are they going to see you as someone who has a solid understanding of this study and presents a good argument? Or are they going to think you don't have a clue what you're talking about?

The difference is in whether you understand it yourself. If you understand something, you will have the ability to explain it so that others see you as knowledgeable of the subject. If you do not understand something, you're going to come across as someone who doesn't really get it.

Who do you think they'll pay attention to?

You need to make sure you understand this study and what it means before you present your views of it, or they won't take you seriously.

 

[bigdancehawk]

Imagine that someone who works at the FDA is reading your comment. Are they going to see you as someone who has a solid understanding of this study and presents a good argument? Or are they going to think you don't have a clue what you're talking about?

The difference is in whether you understand it yourself. If you understand something, you will have the ability to explain it so that others see you as knowledgeable of the subject. If you do not understand something, you're going to come across as someone who doesn't really get it.

Who do you think they'll pay attention to?

You need to make sure you understand this study and what it means before you present your views of it, or they won't take you seriously.

You explained it quite well and I fully understand it. I wrote the rest of it and here is the whole thing. You'll see I incorporated what you said at the end:

It seems nobody can read the actual study, only a brief abstract.

So all we can do is read the abstract to see if it passes the common sense test. According to the abstract, they asked 15,264 adolescents if they had EVER used e-cigarettes ("lifetime e-cigarette use" is how it's described in the abstract) and also asked if they had recently used conventional cigarettes. Out of all the respondents, 3.2% (488) reported that they "had used e-cigarettes." That is a remarkably low number and hardly supports alarmist claims that adolescents in large numbers are fiendishly puffing on e-cigarettes. Furthermore, It seems they were not asked how recently or how often they had used e-cigarettes, so we have no way of knowing how many just took one puff a few years ago or whether they are, or have ever been, regular users. Of that small group of “ever used,” most if not all were recent smokers of conventional cigarettes. What we’re not told is how many of all the respondents were regular or current conventional cigarette users. Nor are we told how many in that sub-group had ever tried substituting e-cigarettes for conventional cigarettes and, if so, how successful they were. Nor are we told how many in the cigarette smoking group expressed a desire to quit and, if so, by what method. Nor was any attempt made to compare the number of cigarette smokers who had no desire to quit smoking conventional cigarettes with the number of former or current e-cigarette users who likewise had no desire to quit smoking conventional cigarettes. Conversely, the study (judging from the abstract) did not answer this simple but important question: if the very small percentage of former or current e-cigarette “users” did not use it as a smoking cessation aid, WHY did they use them?

So, we’re left with a bare, unsubstantiated conclusion, without even a glimpse at the results which supposedly support it: “E-cigarette use . . . does not appear to be part of a cessation regimen among conventional cigarette smokers wishing to quit.”

Now, let’s compare that with what Dr. Spangler claims the study shows: “Adolescents do not use e-cigarettes as cessation aids, but rather use them in conjunction with conventional cigarettes (58-fold greater risk of use among smokers).”

The study does not support either of Dr. Spangler's claims. If the study had asked all of the current and former conventional cigarette users in this group of 15,264 if they used e-cigarettes for smoking cessation and reported the results, then, depending on the results, Dr. Spangler might have been able to say, “Adolescents do not use e-cigarettes as cessation aids.” But apparently the study didn’t do that and so it provides no support for Dr. Spangler’s "tobacco control" ideology. The study merely showed that 488 adolescents out of a group of 15,264 had at one time or another used an e-cigarette, that some of them were currently smoking conventional cigarettes, and that they had no present desire to quit. Given the fact that they had no present desire to quit, it is hardly surprising that they were not using e-cigarettes as cessation aids. It may also be true that, even though they have no present desire to quit, they may find e-cigarettes more to their liking than conventional cigarettes and simply quit smoking as "unintentional quitters." There are thousands posting on the Electronic Cigarette Forum, in case anybody cares to look.

Contrary to Dr. Spangler's assertion, the study did not measure usage of e-cigarettes “in conjunction with conventional cigarettes.” It merely established that most of the adolescents who had at any time used or tried an e-cigarette, even if they only took one puff, were also recent users of conventional cigarettes and had no present desire to quit.

As for the raw statistical data:

Interpreting odds ratios according to the NIH:
OR=1 Exposure does not affect odds of outcome
OR>1 Exposure associated with higher odds of outcome
OR<1 Exposure associated with lower odds of outcome

In other words, compare the figure they give you to 1. Higher than 1 = higher odds, lower than 1 = lower odds. These are ratios comparing two contrasting variables. You just have to know what the opposite variable is. So for example, in this study:
Female OR is 0.70 => For every 1 male that tries e-cigarettes, 0.7 females do. Or, for every 10 males who try it, 7 females do.
Smoker OR is 58.44 => For every 1 nonsmoker that tries e-cigarettes, 58.44 smokers try it. This is strong evidence that nonsmoking teens have virtually no interest in e-cigarettes.

This study proves what vapers know to be true, and has been shown in other studies: when kids try e-cigarettes, chances are they already smoke.

When they say, "Among conventional cigarette smokers, neither desire to quit nor recent quit attempts is significantly associated with e-cigarette use," they are giving NO data to support this in the abstract, and thus there is no data present to support their conclusion.

 

[dragonpuff]

You explained it quite well and I fully understand it. I wrote the rest of it and here is the whole thing. You'll see I incorporated what you said at the end:

It seems nobody can read the actual study, only a brief abstract.

So all we can do is read the abstract to see if it passes the common sense test. According to the abstract, they asked 15,264 adolescents if they had EVER used e-cigarettes ("lifetime e-cigarette use" is how it's described in the abstract) and also asked if they had recently used conventional cigarettes. Out of all the respondents, 3.2% (488) reported that they "had used e-cigarettes." That is a remarkably low number and hardly supports alarmist claims that adolescents in large numbers are fiendishly puffing on e-cigarettes. Furthermore, It seems they were not asked how recently or how often they had used e-cigarettes, so we have no way of knowing how many just took one puff a few years ago or whether they are, or have ever been, regular users. Of that small group of “ever used,” most if not all were recent smokers of conventional cigarettes. What we’re not told is how many of all the respondents were regular or current conventional cigarette users. Nor are we told how many in that sub-group had ever tried substituting e-cigarettes for conventional cigarettes and, if so, how successful they were. Nor are we told how many in the cigarette smoking group expressed a desire to quit and, if so, by what method. Nor was any attempt made to compare the number of cigarette smokers who had no desire to quit smoking conventional cigarettes with the number of former or current e-cigarette users who likewise had no desire to quit smoking conventional cigarettes. Conversely, the study (judging from the abstract) did not answer this simple but important question: if the very small percentage of former or current e-cigarette “users” did not use it as a smoking cessation aid, WHY did they use them?

So, we’re left with a bare, unsubstantiated conclusion, without even a glimpse at the results which supposedly support it: “E-cigarette use . . . does not appear to be part of a cessation regimen among conventional cigarette smokers wishing to quit.”

Now, let’s compare that with what Dr. Spangler claims the study shows: “Adolescents do not use e-cigarettes as cessation aids, but rather use them in conjunction with conventional cigarettes (58-fold greater risk of use among smokers).”

The study does not support either of Dr. Spangler's claims. If the study had asked all of the current and former conventional cigarette users in this group of 15,264 if they used e-cigarettes for smoking cessation and reported the results, then, depending on the results, Dr. Spangler might have been able to say, “Adolescents do not use e-cigarettes as cessation aids.” But apparently the study didn’t do that and so it provides no support for Dr. Spangler’s "tobacco control" ideology. The study merely showed that 488 adolescents out of a group of 15,264 had at one time or another used an e-cigarette, that some of them were currently smoking conventional cigarettes, and that they had no present desire to quit. Given the fact that they had no present desire to quit, it is hardly surprising that they were not using e-cigarettes as cessation aids. It may also be true that, even though they have no present desire to quit, they may find e-cigarettes more to their liking than conventional cigarettes and simply quit smoking as "unintentional quitters." There are thousands posting on the Electronic Cigarette Forum, in case anybody cares to look.

Contrary to Dr. Spangler's assertion, the study did not measure usage of e-cigarettes “in conjunction with conventional cigarettes.” It merely established that most of the adolescents who had at any time used or tried an e-cigarette, even if they only took one puff, were also recent users of conventional cigarettes and had no present desire to quit.

As for the raw statistical data:

Interpreting odds ratios according to the NIH:
OR=1 Exposure does not affect odds of outcome
OR>1 Exposure associated with higher odds of outcome
OR<1 Exposure associated with lower odds of outcome

In other words, compare the figure they give you to 1. Higher than 1 = higher odds, lower than 1 = lower odds. These are ratios comparing two contrasting variables. You just have to know what the opposite variable is. So for example, in this study:
Female OR is 0.70 => For every 1 male that tries e-cigarettes, 0.7 females do. Or, for every 10 males who try it, 7 females do.
Smoker OR is 58.44 => For every 1 nonsmoker that tries e-cigarettes, 58.44 smokers try it. This is strong evidence that nonsmoking teens have virtually no interest in e-cigarettes.

This study proves what vapers know to be true, and has been shown in other studies: when kids try e-cigarettes, chances are they already smoke.

When they say, "Among conventional cigarette smokers, neither desire to quit nor recent quit attempts is significantly associated with e-cigarette use," they are giving NO data to support this in the abstract, and thus there is no data present to support their conclusion.

I love it! Great comment!!

 

[nomore stinkies]

I read an article regarding a lab rat experiment. They gave the rats(1) pure nicotine and then (2) nicotine with anabasine and 4 other chemicals they thought might be linked to the "addiction" of smoking. Guess which chemicals the rats kept going back to? Yes #2. They left the pure nicotine and went for the gold.

As with everything there are risks. We sign medical consent forms saying that we might die if we proceed. We take drugs with a list of possible side affects. We make decisions for risk on a daily basis. Heck we can't walk across the street without risk.

I ran out of things to say, so I started reading some of the negative comments about e-cigarettes. You can screen out the cigar comments by running a search for "e-cigarettes" or "electronic cigarettes."

I've spent most of my day commenting on the negative comments. [EDIT: I need to get a life]. Here's one of mine:

A Ph.D should document his "facts." It never ceases to amaze me that some PhDs make statements of alleged "facts" which can be disproved with a one minute Google search.

1. "Nicotine is a very toxic substance..." And therefore, what? That can be said of many common household and garden products, all of which have appropriate warning labels and which nobody opposes for e-liquids. The highest concentration of nicotine in e-juice I've seen is 36mg/ml. I've spilled it on myself several times and it hasn't even caused a rash, much less "accidental poisoning." And it's highly soluble in water, so it's easily rinsed off. Out of all the millions of people using e-cigarettes all over the world for a number of years, there is not a single reported instance of a fatal accidental poisoning and only a minuscule number of reports involving any degree significant harm. For example, in the UK, where there are an estimated 2 million e-cigarette users, there were only two reports involving children suffering symptoms lasting more than a few hours and none with permanent ill-effects. E-cigarette poisoning figures soar as vaping habit spreads across UK | Society | The Guardian

Phone inquiries to poison control centers are not documented cases of poisoning, although one would never know that from reading sensationalist headlines. If we were to over-regulate everything that might harm children, then adults will all be forced to live in padded cells.

2. "Nicotine is highly associated with the development of physical dependence..." Actually it isn't. Nicotine in combination with all the many other substances in combustible tobacco is associated with physical dependence. There has not been a single study done on humans showing that nicotine alone produces significant dependence. Is Nicotine Addictive ? The animals it's been tested on don't show signs of significant physical dependence. People using nicotine gum don't develop significant physical dependence, nor do people using patches, inhalers and lozenges. I feel reasonably sure that that FDA knows these things, as it has approved these products for long term use as smoking cessation aids. The absurd analogy comparing electronic cigarettes to EDIT: the prevalent cash crop in Afghanistan casts a dark shadow over every other undocumented statement this gentlemen has made.

3. "Although e-cigarettes do not release second-hand combustion products at a level equivalent to smoked tobacco.." What was that again? E-cigarettes do not release ANY level of combustion products. And the claim that e-cigarettes "release significant amounts of nicotine in exhalations" is false. Peer reviewed studies have NOT detected significant levels of nicotine in the air from the use of e-cigarettes, even in enclosed, unventilated rooms. Here is a link to one such study: http://clearstream.flavourart.it/site/wp-content/uploads/2012/09/CSA_ItaEng.pdf
That study concluded, "5 vapers using e-cigarettes for 5 h in a small room without renewal of indoor air do not produce
detectable levels of nicotine in the air."

 

[aikanae1]

IMO if ecigarettes were a gateway to smoking, wouldn't the smoking rates be rising instead of dropping? I think that's concrete proof since ecigarettes have been around long enough to appear in trends.

 

[dragonpuff]

IMO if ecigarettes were a gateway to smoking, wouldn't the smoking rates be rising instead of dropping? I think that's concrete proof since ecigarettes have been around long enough to appear in trends.

Unfortunately for us, correlation does not mean causation though I agree that smoking rates are most likely dropping now due to an increase in e-cigarette use, ANTZ could just as easily turn around and say it's because all of their anti-smoking and "For The Children!!!" campaigns are working truth is, there isn't enough evidence to say for sure either way. They could also just as easily say that e-cigarettes just haven't been out long enough to increase smoking rates...

I think clearer evidence for our view are the adolescent studies that have been coming out recently showing that it's teens who smoke that try e-cigarettes, and teens who don't smoke are highly unlikely to do so these studies make it crystal clear that e-cigs are almost universally used by smokers and former smokers, and therefore there is little risk of them "renormalizing" smoking.

 

[aikanae1]

I think it's all in framing the questions which right now the FDA is doing. Most of their questions are leading and ask for evidence to ban ecigs. There's a "girrrl scientist" blog which points out that almost any answer given to them will lead them to the same conclusions.

 

[pamdis]

I think it's all in framing the questions which right now the FDA is doing. Most of their questions are leading and ask for evidence to ban ecigs. There's a "girrrl scientist" blog which points out that almost any answer given to them will lead them to the same conclusions.

Funny you should mention that. Here are snippets of the comment I just finished posting where I called them out on it:

I would like to address the following request for comment found in the Executive Summary of the proposed regulations:

2. FDA is aware that some tobacco products, such as e-cigarettes and certain cigars, are being marketed with characterizing flavors, and that these flavors can be especially attractive to youth. The prohibition against characterizing flavors established in the Tobacco Control Act applies to cigarettes only. FDA requests comments on the characteristics or other factors it should consider in determining whether a particular tobacco product is a "cigarette" as defined in section 900(3) of the FD&C Act and, consequently, subject to the prohibition against characterizing flavors, despite being labelled as a little cigar or other non-cigarette tobacco product. FDA is also seeking research regarding the long-term effects of flavored tobacco product usage including data as to the likelihood of whether users of flavored tobacco products initiate cigarette usage and/or become dual users with cigarettes.​

The tone of this request seems to indicate that the decision to prohibit flavors has already been made. I would like to make the following points in order to deter FDA from proceeding with this decision.

...........{made some points here}

Asking the public to help you redefine smoking alternatives as cigarettes in order to circumvent the law, and asking for research for only one side of an issue is disingenuous and certainly not in the spirit of making science based decisions.

FDA must not simply seek to prohibit flavors, but must also consider the impact of that decision. FDA should also be asking for research on how many alternative smoking product users would return to smoking if flavors were banned.

...........{personal story here}

If you regulate the market to the point that there are only cigalike products with only tobacco flavors, I know I will return to smoking. I suspect that many others will too. FDA must take into consideration all the current users of these products and must acknowledge the fact that these regulations, instead of decreasing smoking, may have the opposite effect of increasing it.