FDA Please keep up the FDA comments everybody!

[dragonpuff]

I was reading through the comment docket and happened across this:

"Would a cigar or e-cigarette look any different to you in the mouth of your 6 year old?"

8-o

On the positive side, I am running across many, MANY comments from vapers and supporters!

Please keep commenting everybody! We need our numbers and our strong words to counteract these ignorant minds!

 

[Rlrick]

I was reading through the comment docket and happened across this:

"Would a cigar or e-cigarette look any different to you in the mouth of your 6 year old?"

8-o

On the positive side, I am running across many, MANY comments from vapers and supporters!

Please keep commenting everybody! We need our numbers and our strong words to counteract these ignorant minds!

You know the old saying " Sticks and stones may break my bones but words shall never harm me" Well what we need to do is replace the sticks and stones with MONEY. By striking them in the heart and eliminating smoking all together think of how much damage we as VAPERS would do. This is why I talk to as many Smokers as I possibly can. And do my very best to convert them to vaping. Instead of sitting in my car vaping I will stand beside it and vape up a storm. I get all kinds of reactions so just be prepared to answer the questions.

 

[dragonpuff]

You know the old saying " Sticks and stones may break my bones but words shall never harm me" Well what we need to do is replace the sticks and stones with MONEY. By striking them in the heart and eliminating smoking all together think of how much damage we as VAPERS would do. This is why I talk to as many Smokers as I possibly can. And do my very best to convert them to VAPING. Instead of sitting in my car vaping I will stand beside it and vape up a storm. I get all kinds of reactions so just be prepared to answer the questions.

I agree, but FDA personnel are not watching you vape outside your car (I hope ). They are asking for comments on the deeming regulation, and I think it's best to make sure we outnumber the anti-vaping posts like the jack hole I quoted above, because it's people like him who are saying what they want to hear. If our numbers are not overwhelming enough, those are the people the FDA will listen to. Then many of us will be stuck putting our money right back into the pockets of tobacco companies for their crummy e-cigs, and I do not want to see that happen...

 

[bigdancehawk]

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."

 

[bigdancehawk]

Here's another one of my attempts at rebuttal:

Well, then this person's work in the field of "asthma education" should have educated herself to the fact that propylene glycol is used in asthma inhalers.

There is no evidence that non-smokers are becoming addicted to e-cigarettes. Rather, as thousands of comments here demonstrate, e-cigarettes are a relatively safe and effective way for smokers to become UNADDICTED to their infinitely more harmful smoking habit.

And I pity the FDA employees who are supposed to wade through comments like that one. You'd think these commentators would at least have the courtesy to hit the return key once in awhile.

 

[dragonpuff]

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. 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."

This is exactly why I've been filling up the docket with pdf attachments of scientific studies.

The FDA knows darn well that nicotine is far less addictive when separated from the other compounds in tobacco. That's one of the reasons they approved NRTs for long term use. Otherwise, it's a moot point, because no matter how addictive nicotine is, that doesn't make it automatically dangerous. It just makes it addictive.

I've run across a lot of people writing in the docket with advanced degrees, and those on the opposing side are generally pulling their data from smoking studies only. Their arguments don't hold water. Saying it's toxic doesn't hold water either - everything is toxic in high enough amounts.

One of my professors at the university I recently graduated from studied nicotine and its analogues. She found that many other chemicals in tobacco, including substances like nornicotine, cotinine, and anabasine acted on cells almost exactly the same way nicotine did. That would amplify the psychoactive effects by a lot. I would link a couple of those studies to the FDA as well but I honestly don't think they're capable of reading them

 

[bigdancehawk]

One of my professors at the university I recently graduated from studied nicotine and its analogues. She found that many other chemicals in tobacco, including substances like nornicotine, cotinine, and anabasine acted on cells almost exactly the same way nicotine did. That would amplify the psychoactive effects by a lot. I would link a couple of those studies to the FDA as well but I honestly don't think they're capable of reading them

Well, they had better learn. If I were you I'd go ahead and send the links, perhaps accompanied by a brief "Molecular Biology/Pharmacology/Toxicology for Dummies" lesson.

EDIT to add: Here's another example of my comments on comments:

"I am 100% for more stringent regulation of nicotine products including e-cigarettes and cigars. It is very concerning to see the increase in middle and high school students that are using the e-cigarette products."

Define "using." Are they actually "using" them or perhaps only tried them once? Kids will try almost anything. There is no evidence to indicate that adolescents who are not smokers trying to quit are taking up an e-cigarette habit.

"The advertisement and marketing of these very addictive products appears to be geared towards creating a whole new generation of addicts and not towards helping people to quit smoking conventional cigarettes."

There's no evidence that they are particularly "addictive," any more that patches, gum, inhalers and lozenges are addictive. Why don't we see kids lots of kids chewing nicotine gum or sucking on nicotine lozenges? They're not prohibited from buying it over the counter at the local drug store. That didn't seem to be much of a concern when the FDA approved them for sale over the counter. And I guess the advertising isn't working, because nearly all e-cigarette users are people who have quit smoking or are trying to quit.

"As a Registered Respiratory Therapist I see the consequences of Tobacco Abuse daily and am very alarmed at the growth of the e-cigarette industry. We see patients who come into the hospital very proud of quiting [sic] cigarettes who don't understand why they are getting sicker only to find out that they are using the e-cigarettes, which are causing them to have further health issues."

Bunk. (My scientific term for improbable anecdotes). Correlation is not causation. How about some evidence? What "further health issues"? Could it be they're sick from all the smoking they did? Maybe they're sick for some other reason. There is no evidence that e-cigarettes, which have been used by millions of people all over the world for a number of years, are causing significant health "issues."

"The harmful consequences of these products especially upon developing bodies is not yet fully known and they are being marketed as a harmless alternative to cigarettes."

So, would you rather have them smoking cigarettes? We DO KNOW how harmful those are. E-cigarettes aren't being "marketed as harmless." Find me one vendor who claims that. They are certainly much less harmful than conventional cigarettes. Even Mr. Zeller knows that, although I don't believe vendors are allowed to make that claim either.

"Inhaling an oil based product of unknown quantities of irritatants [sic] into the airway is inherently a bad idea. Not knowing what is exactly in the products is especially concerning."

"Oil based"? Now there's a scary term. Propylene glycol is used in asthma inhalers. Hospitals spray mists of it in the air to combat bacteria. It's given to lung transplant patients. It's used in stage productions to simulate smoke. If this person is a respiratory therapist, he/she should know these things. Vegetable glycerin isn't oil based. And we do know "what is exactly in the products." They contain PG and/or VG, nicotine and FDA approved food flavorings. There's no evidence that any of these substances are carcinogens and there are mounds of evidence that they aren't. That's a far cry from the thousands of toxins in cigarette smoke.

 

[dragonpuff]

Well, they had better learn. If I were you I'd go ahead and send the links, perhaps accompanied by a brief "Molecular Biology/Pharmacology/Toxicology for Dummies" lesson.

There is a brief lesson on these subjects for dummies - it's called a 4 year university sequence in biochemistry!

Honestly I can barely read the professor's studies myself. In the words of Marty McFly, they're "heavy." I will try to dig up some more user-friendly information on the topic though.

I love your rebuttals! Keep it up, you're doing great! as for the "Registered Respiratory Therapist," the fact that she can't spell and doesn't know which words should be capitalized speaks volumes about her expertise in my opinion.

 

[bigdancehawk]

There is a brief lesson on these subjects for dummies - it's called a 4 year university sequence in biochemistry!

Honestly I can barely read the professor's studies myself. In the words of Marty McFly, they're "heavy." I will try to dig up some more user-friendly information on the topic though.

I love your rebuttals! Keep it up, you're doing great! as for the "Registered Respiratory Therapist," the fact that she can't spell and doesn't know which words should be capitalized speaks volumes about her expertise in my opinion.

Perhaps she is the same respiratory therapist whose hospital I'm now suing because she injected a number of patients with lethal doses of succinylcholine and/or insulin. Here, if you're curious, you can read about it: http://www.courts.mo.gov/file.jsp?id=67808

 

[dragonpuff]

Perhaps she is the same respiratory therapist whose hospital I'm now suing because she injected a number of patients with lethal doses of succinylcholine and/or insulin. Here, if you're curious, you can read about it: http://www.courts.mo.gov/file.jsp?id=67808

What a tragedy that is horrible.

It goes to show that not all medical personnel can be trusted...

 

[dragonpuff]

My latest comment to the FDA:

It has come to my attention that Judge Leon ruled that you are to replace those members of the Tobacco Product Scientific Advisory Committee (TPSAC) who have conflicts of interest with pharmaceutical companies. It is now painfully clear to me (and many others as well) why the FDA feels it is necessary to treat all tobacco products as equally dangerous when this is clearly not the case and could prevent further reduction of smoking rates.

I would ask that the FDA thoroughly revise the deeming regulations with advisement of the new members of TPSAC, taking into account all balanced scientific studies regarding harm reduction strategies. Despite the obvious catering to pharmaceutical corporations, the primary responsibility of the FDA is still to protect and improve public health and they are expected to do so.

I came thisclose to telling them they should be ashamed of themselves

 

[roach52]

I have been submitting comments regularly. It seems the antz are as well there are hundreds of identical "stop marketing to kids, ban flavors" in there. In the sample I looked at probably 5 of these form letter comments to every 1 from those of us who support vapeing. Very annoying, but not suprised.

 

[dragonpuff]

I have been submitting comments regularly. It seems the antz are as well there are hundreds of identical "stop marketing to kids, ban flavors" in there. In the sample I looked at probably 5 of these form letter comments to every 1 from those of us who support vapeing. Very annoying, but not suprised.

I noticed that too... that's exactly why we need to make sure our voices are at least as loud.

My local B&M are doing giveaways every day on facebook this month. For today, in order to enter your name in the drawing you have to comment how long you have been vaping. In the two hours since they posted there have been 166 comments. It doesn't sound like much offhand but when you read over the individual comments... each and every one of these people have cut back or quit smoking using electronic cigarettes. Every single one of those comments represents a life saved.

Seeing that motivates me so much more to fight these regulations!

 

[bigdancehawk]

Maybe somebody who understands logistic regression can help me with this.

I'm working on a rebuttal to a physician's comment on the deeming regulation. His comment relies on a cross-sectional study of about 15,000 adolescents which reported: "Descriptive analyses show 3.2% of respondents had used e-cigarettes. E-cigarette use is significantly lower for females (adjusted odds ratio [OR], .70, non-Hispanic black youth (adjusted OR, .47), and Mexican American youth (adjusted OR, .56), and higher for those who smoke conventional cigarettes (adjusted OR, 58.44) or have friends who smoke (adjusted OR 2.38)."

According to the abstract, "Among conventional cigarette smokers, neither desire to quit nor recent attempts is significantly associated with e-cigarette use. [the abstract contains no data supporting this statement] Conclusions: E-cigarette use is more common among certain adolescent subgroups than others and does not appear to be part of a cessation regimen among conventional cigarette smokers wishing to quit. More regulatory and prevention efforts are needed, especially for certain adolescent subpopulations."

Here's a broken link to the abstract: http:**//www**.ncbi.nlm.nih.gov/pubmed/24968185

The actual study hasn't been published, so we can't read it, know who funded it, evaluate the credentials of those who performed it, know what conflicting interests they may have, determine who (if anyone) reviewed it, or learn anything about the methodology.

But my question is this: I had the vague impression that adjusted odds ratios were for comparing two or more groups as in, for example, a clinical trial where you have one group given a particular drug and a control group given a placebo or some other drug. So, how do you translate an OR of 58.44 into a percentage or a probability? All I can figure out is that most of the kids who have ever tried an e-cigarette, even if just once in their life, are analog cigarette smokers.

Regarding the part in bold: It may be that the study supports that conclusion, but I doubt it. It certainly isn't supported by the little bits of data in the abstract. And I find it hard to believe that none of the cigarette smokers had ever tried e-cigarettes as a smoking cessation aid, given the fact that that's what almost everybody uses them for.

So, can anybody help an English major make sense of this so maybe I can shoot some holes in it?

 

[DrMA]

When vapers say we inadvertently quit smoking with vaping, despite having no intention to do so, these ANTZ will interpret it as «does not appear to be part of a cessation regimen». Rule#1 of junk science: *everything* can be claimed to support your predetermined conclusion.

 

[bigdancehawk]

When vapers say we inadvertently quit smoking with vaping, despite having no intention to do so, these ANTZ will interpret it as «does not appear to be part of a cessation regimen». Rule#1 of junk science: *everything* can be claimed to support your predetermined conclusion.

Oh, you're absolutely right and there are many personal stories posted here and elsewhere by vapers who did just that. What I'm trying to focus on now is this doctor's statement that the study in question 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).”

He got the "58-fold greater risk" from the adjusted OR of 58.44 that's in the study's abstract. Does an OR of 58.44 translate into 58 fold? I recall reading somewhere that odds ratios don't translate very well into probabilities, especially if the OR is a large number. In other words, if you're not careful, you can end up with a 500% probability that it will rain tomorrow.

 

[dragonpuff]

Maybe somebody who understands logistic regression can help me with this.

I'm working on a rebuttal to a physician's comment on the deeming regulation. His comment relies on a cross-sectional study of about 15,000 adolescents which reported: "Descriptive analyses show 3.2% of respondents had used e-cigarettes. E-cigarette use is significantly lower for females (adjusted odds ratio [OR], .70, non-Hispanic black youth (adjusted OR, .47), and Mexican American youth (adjusted OR, .56), and higher for those who smoke conventional cigarettes (adjusted OR, 58.44) or have friends who smoke (adjusted OR 2.38)."

According to the abstract, "Among conventional cigarette smokers, neither desire to quit nor recent attempts is significantly associated with e-cigarette use. [the abstract contains no data supporting this statement] Conclusions: E-cigarette use is more common among certain adolescent subgroups than others and does not appear to be part of a cessation regimen among conventional cigarette smokers wishing to quit. More regulatory and prevention efforts are needed, especially for certain adolescent subpopulations."

Here's a broken link to the abstract: http:**//www**.ncbi.nlm.nih.gov/pubmed/24968185

The actual study hasn't been published, so we can't read it, know who funded it, evaluate the credentials of those who performed it, know what conflicting interests they may have, determine who (if anyone) reviewed it, or learn anything about the methodology.

But my question is this: I had the vague impression that adjusted odds ratios were for comparing two or more groups as in, for example, a clinical trial where you have one group given a particular drug and a control group given a placebo or some other drug. So, how do you translate an OR of 58.44 into a percentage or a probability? All I can figure out is that most of the kids who have ever tried an e-cigarette, even if just once in their life, are analog cigarette smokers.

Regarding the part in bold: It may be that the study supports that conclusion, but I doubt it. It certainly isn't supported by the little bits of data in the abstract. And I find it hard to believe that none of the cigarette smokers had ever tried e-cigarettes as a smoking cessation aid, given the fact that that's what almost everybody uses them for.

So, can anybody help an English major make sense of this so maybe I can shoot some holes in it?

My dissection of this abstract:

They found that 3.2% of the adolescents had tried e-cigarettes (read: 3 out of 100 people). This is stunningly low. If e-cigarettes were trendy among youth, or if flavors or advertising were actually attracting youth, you would expect this number to be quite a bit higher.

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 gave 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! Wow!
Likewise, those who have friends that smoke are more than twice as likely to try e-cigarettes as those who don't.

This study proves what we 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. We need to wait for the rest of the study to come out before we can make that conclusion (or refute it) ourselves.

Does that help?

Edit: If there are any errors in my analysis, please feel free to correct me! I did this while half asleep...

 

[bigdancehawk]

Oh yeah! Can I just copy and paste some of that in my rebuttal?

 

[dragonpuff]

Oh yeah! Can I just copy and paste some of that in my rebuttal?

Ha ha if you must. You really didn't need my permission though, if I were going to write the rebuttal myself I would have said so just make sure you understand exactly what you're writing (or what I wrote) before you post it!

 

[bigdancehawk]

Ha ha if you must. You really didn't need my permission though, if I were going to write the rebuttal myself I would have said so just make sure you understand exactly what you're writing (or what I wrote) before you post it!

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