Study by prohibitionists finds e-cigarettes reduce cigarette consumption 40% among first time users, but authors misrepresent findings

[Bill Godshall]

Study (presented as a poster at last week's SRNT conference) by e-cigarette prohibitionists finds 40% decline in mean daily cigarette consumption (from 14.7 to 8.8) among 43 first time e-cigarette users who weren't interested in quitting smoking, but authors falsely claim tobacco toxicant exposure WAS NOT lowered, that "e-cigs may provide no public health benefit", and that their findings support FDA regulation of e-cigarettes as Modified Risk tobacco Products (which would first require FDA to approve a "deeming" regulation that could/would effective ban e-cigarette sales).
http://www.srnt.org/conferences/2012/pdf/2012_Abstracts_H.pdf (POS3-107 on page 121)

POS3-107
E-CIGARETTE ABUSE LIABILITY: SUBJECTIVE, BEHAVIORAL, AND EXPOSURE
EFFECTS OF SWITCHING
Vaughan W. Rees*, Jonathan Noel, Ilan Behm, and Gregory N. Connolly, Center for
Global tobacco Control, Harvard School of Public Health

BACKGROUND: Electronic cigarettes have been promoted as a safer alternative for
delivering nicotine to smokers. However, the appeal of the e-cigarette (e-cig) may be
limited compared with a conventional cigarette. Abuse liability of e-cig was assessed
among daily smokers using a switching study design. METHODS: Participants (N=
43; 35.4 yrs of age; 70% male) were regular smokers not contemplating quitting,
and were naive to e-cig use. After a 72 hour baseline of usual brand of conventional
cigarette use, subjects were switched for a further 11 days to a commercial e-cig
product. Behavior was monitored throughout the study (smoking diary, phone interview)
and follow-up lab sessions were conducted at Days 11 and 14. Puffing topography,
smoking urges, nicotine withdrawal, sensory perceptions, and drug effect and liking
were measured pre- and post-smoking. Exposure to nicotine was assessed via urinary
cotinine pre- and post-switching. RESULTS: After 14 days, mean cigarettes smoked
per day significantly decreased a relative 40.3% from 14.7 at baseline to 8.8 at Day
14 (paired t-test, p<0.001). Subjects took larger (p=.045) and longer (p=.008) puffs
with the e-cig compared with conventional. Cotinine geometric mean did not differ
significantly from baseline to Day 14 (1535.9 ng/ml vs. 1391.7 ng/ml; p<.001). E-cig
use reduced urges to smoke (p=.046) and withdrawal (p=.046). However, e-cig nicotine
effect (p=.006) and liking (p<.001) were rated significantly lower than the conventional
cigarette. CONCLUSIONS: E-cigarette use reduced smoking urges and withdrawal,
but nicotine effect and liking measures suggested a less optimal e-cig nicotine reward.
While conventional cigarette consumption decreased, complete switching did not occur,
further suggesting limited consumer appeal. These data suggest that e-cigs have lower
abuse liability compared with conventional cigarettes and are likely to be used dually
with conventional cigarettes. The failure to lower exposure to tobacco toxicants, while
maintaining nicotine dependence, suggests that e-cigs may provide no public health
benefit. These findings support FDA regulation of e-cigarettes as Modified Risk Tobacco
Products.
National Cancer Institute grant # RO1-CA-125224.
CORRESPONDING AUTHOR: Vaughan Rees, PhD, Harvard School of Public Health,
Center for Global Tobacco Control, 677 Huntington Ave, Boston, MA 02115, United
States, Phone: 617-496-1395, Email: vrees@hsph.harvard.edu

 

[markfm]

The intro on the Method says it all.

"Participants (N=43; 35.4 yrs of age; 70% male) were regular smokers not contemplating quitting,
and were naive to e-cig use."

New people who aren't interested in stopping/switching. That there was still a 40% reduction in smoking is pretty amazing.

"Hey, guy, you don't want to stop smoking, but mind trying a Schnoo ecig for a couple weeks? It's fine to smoke, too, just tell us what you feel like using. Oh, yeah, it's likely a pretty cruddy ecig, and, well, we aren't even sure how you should use it, don't know about how to inhale, or drink extra water, or..., but press on and let us know what happens."

 

[Bill Godshall]

I sent the following e-mail to Vaughan Rees.


Hi Vaughan,

I noticed your poster presentation for the SRNT conference and found it extremely inconsistent.
http://www.srnt.org/conferences/2012/pdf/2012_Abstracts_H.pdf (POS3-107 on page 121 and printed below)

Please explain how a 40% decline in mean daily cigarette consumption (from 14.7 to 8.8) did NOT lower tobacco toxicant exposure for the 43 first time e-cigarette users in your study. In fact, a 40% decline in cigarette consumption is about a 40% decline in tobacco toxicant exposure (since the smoke is the toxicant).

Also, please explain how did you conclude that a 40% decline in mean daily cigarette consumption "may provide no public health benefit". Do you similarly believe that a 40% increase in daily cigarette consumption would benefit public health?

Finally, please explain how your study's findings support FDA regulation of e-cigarettes as Modified Risk Tobacco Products (since MRTP applications can only be submitted by manufacturers of cigarettes, cigarette tobacco, RYO and smokeless tobacco, and since FDA would first need to promulgate a "deeming" regulation to apply Chapter IX provisions of the FSPTCA to e-cigarettes before any e-cigarette company could even submit a MRTP application, and since the promulgation of a "deeming" regulation for e-cigarettes could/would protect cigarette markets and harm public health by bannign most e-cigarette sales and otherwise decimating the e-cigarette industry).

In fact, none of your study's findings support any regulation(s) for e-cigarettes. Rather, your study found that e-cigarettes could sharply reduce cigarette consumption among first time users, and that e-cigarettes could potentially save tens of millions of lives if smokers were truthfully informed that e-cigarettes are far less hazardous alternatives to cigarettes and if e-cigarettes remain inexpensive, legal and easily accessible.

Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com

POS3-107
E-CIGARETTE ABUSE LIABILITY: SUBJECTIVE, BEHAVIORAL, AND EXPOSURE
EFFECTS OF SWITCHING
Vaughan W. Rees*, Jonathan Noel, Ilan Behm, and Gregory N. Connolly, Center for
Global Tobacco Control, Harvard School of Public Health

BACKGROUND: Electronic cigarettes have been promoted as a safer alternative for
delivering nicotine to smokers. However, the appeal of the e-cigarette (e-cig) may be
limited compared with a conventional cigarette. Abuse liability of e-cig was assessed
among daily smokers using a switching study design. METHODS: Participants (N=
43; 35.4 yrs of age; 70% male) were regular smokers not contemplating quitting,
and were naive to e-cig use. After a 72 hour baseline of usual brand of conventional
cigarette use, subjects were switched for a further 11 days to a commercial e-cig
product. Behavior was monitored throughout the study (smoking diary, phone interview)
and follow-up lab sessions were conducted at Days 11 and 14. Puffing topography,
smoking urges, nicotine withdrawal, sensory perceptions, and drug effect and liking
were measured pre- and post-smoking. Exposure to nicotine was assessed via urinary
cotinine pre- and post-switching. RESULTS: After 14 days, mean cigarettes smoked
per day significantly decreased a relative 40.3% from 14.7 at baseline to 8.8 at Day
14 (paired t-test, p<0.001). Subjects took larger (p=.045) and longer (p=.008) puffs
with the e-cig compared with conventional. Cotinine geometric mean did not differ
significantly from baseline to Day 14 (1535.9 ng/ml vs. 1391.7 ng/ml; p<.001). E-cig
use reduced urges to smoke (p=.046) and withdrawal (p=.046). However, e-cig nicotine
effect (p=.006) and liking (p<.001) were rated significantly lower than the conventional
cigarette. CONCLUSIONS: E-cigarette use reduced smoking urges and withdrawal,
but nicotine effect and liking measures suggested a less optimal e-cig nicotine reward.
While conventional cigarette consumption decreased, complete switching did not occur,
further suggesting limited consumer appeal. These data suggest that e-cigs have lower
abuse liability compared with conventional cigarettes and are likely to be used dually
with conventional cigarettes. The failure to lower exposure to tobacco toxicants, while
maintaining nicotine dependence, suggests that e-cigs may provide no public health
benefit. These findings support FDA regulation of e-cigarettes as Modified Risk Tobacco
Products.
National Cancer Institute grant # RO1-CA-125224.
CORRESPONDING AUTHOR: Vaughan Rees, PhD, Harvard School of Public Health,
Center for Global Tobacco Control, 677 Huntington Ave, Boston, MA 02115, United
States, Phone: 617-496-1395, Email: vrees@hsph.harvard.edu

 

[VapApe]

It seems their trying to say, That being slap up the side of your head with and open hand
Is the same as being hit with a two by four. I would love to demonstrate the differences to them
I think you would have to use the two by four first just to get their attention.

 

[tommy2bad]

What their saying is if it doesn't lead to total cessation then, on the principal that their is no safe amount of tobacco, then it is a failure and of no benefit.
Once you set the complete removal of any and all tobacco products as your goal, then only that which could, might, maybe, lead to that end is acceptable.
It's stops being about what works to reduce and becomes about what will lead to elimination.

 

[Thulium]

It's stops being about what works to reduce and becomes about what will lead to elimination.

When you are completely full of "it", elimination does seem to become the priority.

 

[Bill Godshall]

Vaughan Rees sent me the following reply.

Dear Bill,
Great questions. I have provided responses to your questions below. Please note that the study has not been peer-reviewed and published and that this conference presentation should be considered a preliminary finding until the manuscript is finalized. Also, some further data on exposure were obtained after the abstract was submitted back around September 2011. Consequently, some of the statements made in that abstract have been revised for the poster actually presented.

Regards,
Vaughan

Vaughan Rees, PhD
Center for Global Tobacco Control
Dept. Society, Human Development and Health
Harvard School of Public Health
Landmark Building, Level 3 East
677 Huntington Ave
Boston, MA 02115
Ph. 617-496-1395


>>> "Bill Godshall" <smokefree@compuserve.com> 3/28/2012 2:03 PM >>>

Hi Vaughan,

I noticed your poster presentation for the SRNT conference and found it extremely inconsistent.
http://www.srnt.org/conferences/2012/pdf/2012_Abstracts_H.pdf (POS3-107 on page 121 and printed below)

Please explain how a 40% decline in mean daily cigarette consumption (from 14.7 to 8.8) did NOT lower tobacco toxicant exposure for the 43 first time e-cigarette users in your study. In fact, a 40% decline in cigarette consumption is about a 40% decline in tobacco toxicant exposure (since the smoke is the toxicant).
There was a significant decrease in NNAL, indicating that NNK exposure was decreased. Cotinine was not significantly decreased, suggesting that the e-cig maintained users' nicotine requirement while cigarette consumption reduced.
The decrease in NNAL is certainly a positive step, but likely falls far short of providing substantial reduction in health risk. This question requires further evidence to be established.

Also, please explain how did you conclude that a 40% decline in mean daily cigarette consumption "may provide no public health benefit". Do you similarly believe that a 40% increase in daily cigarette consumption would benefit public health?
The concern is that reduction in smoking will not eliminate risk and may delay cessation among some smokers.

Finally, please explain how your study's findings support FDA regulation of e-cigarettes as Modified Risk Tobacco Products (since MRTP applications can only be submitted by manufacturers of cigarettes, cigarette tobacco, RYO and smokeless tobacco, and since FDA would first need to promulgate a "deeming" regulation to apply Chapter IX provisions of the FSPTCA to e-cigarettes before any e-cigarette company could even submit a MRTP application, and since the promulgation of a "deeming" regulation for e-cigarettes could/would protect cigarette markets and harm public health by bannign most e-cigarette sales and otherwise decimating the e-cigarette industry).
The poster presented at the meeting (in contrast with the earlier abstract) concludes:
"Smokers reported generally unfavorable responses to e-cigarette use, including e-cigarette effect and liking, lower perceptions of product sensory appeal, and withdrawal reduction. However, smokers replaced 40% of their conventional cigarette consumption with e-cigarette use, and maintained cotinine levels, while reducing urinary NNAL. E-cigarettes may promote dual use rather than complete switching, and the influence of dual e-cig/conventional product use on individual risk requires further investigation."
This evidence may contribute to the science base for FDA regulation, which may require a "deeming" regulation as you have stated.


In fact, none of your study's findings support any regulation(s) for e-cigarettes. Rather, your study found that e-cigarettes could sharply reduce cigarette consumption among first time users, and that e-cigarettes could potentially save tens of millions of lives if smokers were truthfully informed that e-cigarettes are far less hazardous alternatives to cigarettes and if e-cigarettes remain inexpensive, legal and easily accessible.
I don't think those conclusions can be made from this study

Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com

 

[Thulium]

It seems that Dr. Rees has forgotten that this study specifically looked at smokers who were NOT willing to quit. The evidence shows that despite their unwillingness to quit, and without anything in the study encouraging these smokers to quit or cut down, they smoked 40% few cigarettes. How exactly does smoking fewer cigarettes make someone who is otherwise unwilling to quit...less willing to quit?? Are they worried that the people who weren't too excited about needing to quit, might not be willing to shut up about how they can temporarily or permanently avoid the perils of smoking without the need for psychiatric help? Come to think of it, yes, that's probably it.

 

[bruiser]

Perhaps they should find smokers who are wanting to quit, and give them an eGo or other quality PV to use.

 

[Penner]

Perhaps they should find smokers who are wanting to quit, and give them an eGo or other quality PV to use.

You know, to tell you the truth, I don't think I've ever seen a study like that. Great idea.

Also, would like to see (in smokers that want to quit: a 3 arm study):
1. 1 arm being nicotine gum or patch.
2. Second arm is e cigs (& a good version not a gas station one).
3. placebo.

I'd like to see it for whatever the length of time they say the average person stays off cigarettes using the FDA approved nicotine replacement strategy.

 

[Stosh]

40% decline in mean daily cigarette consumption (from 14.7 to 8.8)

Are they kidding, 14.7 cigs a day!!! Is that just counting the ones before you leave for work in the AM??

Perhaps they should have tested smokers......

 

[KeysBum]

I am so sick of politics masquerading as science.

 

[Penner]

Are they kidding, 14.7 cigs a day!!! Is that just counting the ones before you leave for work in the AM??

Perhaps they should have tested smokers......

I've actually been reading some of these posters from that meeting, & they defined 10 cigs a day as a Heavy smoker.

Wow, naiveté abounds in PhDs.

I guess why PhD = Piled Higher & Deeper.

 

[Vocalek]

Vaughan Rees sent me the following reply.


There was a significant decrease in NNAL, indicating that NNK exposure was decreased. Cotinine was not significantly decreased, suggesting that the e-cig maintained users' nicotine requirement while cigarette consumption reduced.

If nicotine were proven to cause cancer, like NNK, then perhaps Rees would be justified in viewing this as a bad thing. But since it isn't, he isn't.

The decrease in NNAL is certainly a positive step, but likely falls far short of providing substantial reduction in health risk. This question requires further evidence to be established.

So why didn't Rees measure anything else? Surely the exposure to tar, particulates, and carbon monoxide was reduced, because smoke contains these things and vapor does not. And actually further evidence does exist, in the form of reports of improved health, even in those who had not completely stopped smoking, in population surveys.

The concern is that reduction in smoking will not eliminate risk and may delay cessation among some smokers.

Did Rees forget that he recruited subjects that had no intentions of smoking cessation? Someone please tell me that Rees isn't suggesting that if smokers can't eliminate all of their risk (quit), they should not bother reducing some of their risks (just die).

The poster presented at the meeting (in contrast with the earlier abstract) concludes:
"Smokers reported generally unfavorable responses to e-cigarette use, including e-cigarette effect and liking, lower perceptions of product sensory appeal, and withdrawal reduction. However, smokers replaced 40% of their conventional cigarette consumption with e-cigarette use, and maintained cotinine levels, while reducing urinary NNAL. E-cigarettes may promote dual use rather than complete switching, and the influence of dual e-cig/conventional product use on individual risk requires further investigation."

Of course it never occurred to these researchers that smokers have differing requirements for nicotine to achieve complete withdrawal elimination, and that the hardware they selected as well as the nicotine concentration in the liquid may have contributed to delivery of sub-therapeutic doses of nicotine--hence the unfavorable response.

Somebody needs to do a study that measures lung function and markers of cardiovascular health before and after smokers achieve a reduction in number smoked due to the evil dual use practice.

This evidence may contribute to the science base for FDA regulation, which may require a "deeming" regulation as you have stated.

Which was probably the aim of this study in the first place.

In fact, none of your study's findings support any regulation(s) for e-cigarettes. Rather, your study found that e-cigarettes could sharply reduce cigarette consumption among first time users, and that e-cigarettes could potentially save tens of millions of lives if smokers were truthfully informed that e-cigarettes are far less hazardous alternatives to cigarettes and if e-cigarettes remain inexpensive, legal and easily accessible.
I don't think those conclusions can be made from this study

Sure they can. Rees just doesn't want to go there.

 

[TomCatt]

40% decline in mean daily cigarette consumption (from 14.7 to 8.8)

Are they kidding, 14.7 cigs a day!!! Is that just counting the ones before you leave for work in the AM??

Perhaps they should have tested smokers......

I've actually been reading some of these posters from that meeting, & they defined 10 cigs a day as a Heavy smoker.

Wow, naiveté abounds in PhDs.

I guess why PhD = Piled Higher & Deeper.

Man, if I had been smoking only 10 cigs a day, I'd never have thought about quitting.

 

[rothenbj]

Man, if I had been smoking only 10 cigs a day, I'd never have thought about quitting.

LOL, when I consider my daily intake and what they considered as "heavy", I smoked for over 400 years and am still posting.

I read an article yesterday where the ANTZ were in full force. One fellow/gal made the statement, to prove the deadliness of smoking, that his brother died of an aneurysm after smoking for 60 years. I just couldn't even reply. If he had started at 15 that would have made him 75. One of my best friends died of the same thing at just over 40 and she didn't smoke. Does that mean smoking gave his brother another 35 years of life?

 

[MattZuke]

Man, if I had been smoking only 10 cigs a day, I'd never have thought about quitting.

I'm sure I've said the same thing, however, with prior cessation attempts I was able to notice the sharp contrast between having 1-2 cigarettes in a day vs having none.