New Vansickel/Weaver/Eissenberg study on e-cigarettes

[Bill Godshall]

A new Vansickel/Weaver/Eissenberg study in Addiction http://onlinelibrary.wiley.com/doi/10.1111/j.1360-0443.2012.03791.x/abstract
has a negative sounding title
Clinical laboratory assessment of the abuse liability of an electronic cigarette
but an objective conclusion
"Electronic cigarettes can deliver clinically significant amounts of nicotine and reduce cigarette abstinence symptoms and appear to have lower potential for abuse relative to traditional tobacco cigarettes, at least under certain laboratory conditions."

I haven't seen any press releases, press conferences or news coverage of this study (in contrast to Eissenberg's past press release and press conference claiming that e-cigarettes emitted no nicotine).

 

[Bill Godshall]

Clinical laboratory assessment of the abuse liability of an electronic cigarette

Andrea R Vansickel Ph.D.1, Michael F Weaver M.D.2, Thomas Eissenberg Ph.D.
Addiction D3DOI: 10.1111/j.1360-0443.2012.03791.x

Abstract

Aims: To provide an initial abuse liability assessment of an electronic cigarette (EC) in current tobacco cigarette smokers.

Design: The first of four, within-subject sessions was an EC sampling session that involved six, 10-puff bouts (30s interpuff interval) with each bout separated by 30-mins. In the remaining three sessions participants made choices between 10 EC puffs and varying amounts of money, 10 EC puffs and a varying number of own brand cigarette (OB) puffs, or 10 OB puffs and varying amounts of money using the multiple-choice procedure (MCP). The MCP was completed six times at 30-min intervals, and one choice was randomly reinforced at each trial.

Setting: Clinical laboratory.

Participants: Twenty current tobacco cigarette smokers.

Measurements: Sampling session outcome measures included plasma nicotine, cardiovascular response, and subjective effects. Choice session outcome was the crossover value on the MCP.

Findings: EC use resulted in significant nicotine delivery, tobacco abstinence symptom suppression, and increased product acceptability ratings. On the MCP, participants chose to receive 10 EC puffs over an average of $1.06 or 3 OB puffs and chose 10 OB puffs over an average of $1.50 (p < .003).

Conclusions: Electronic cigarettes can deliver clinically significant amounts of nicotine and reduce cigarette abstinence symptoms and appear to have lower potential for abuse relative to traditional tobacco cigarettes, at least under certain laboratory conditions.

 

[teissenb]

For the record, I have never conducted a "press conference" in my life.

 

[tommy2bad]

Can some one explain what they did? I'm being thick here but it seems as if they asked "10 puffs on an ecig or 1.06, which would you prefer?"
Or is it that the participants rated the ecig worth about 1.06?
I am no scientist thats for sure.

 

[Bill Godshall]

Tom Eissenberg wrote:

For the record, I have never conducted a "press conference" in my life.

Except that the 2/10/2010 press release from the VCU News Center at
Study Reveals a Need to Evaluate and Regulate 'Electronic Cigarettes' – VCU News Center
includes three videotaped segments of Tom Eissenberg (which appear to have been taped at the VCU Medical Center press office, as the wall behind Tom is a huge ad for VCU Medical Center). Since VCU sent it to various news outlets in an attempt to generate news coverage for Tom (which it did), I consider it accurate to refer to it as a press conference.

In the Thomas Eissenberg 2 and Thomas Eissenberg 3 videoclips, Tom repeatedly states that e-cigarettes emit no nicotine (which isn't correct) and that the FDA should regulate e-cigarettes (which was clearly endorsing FDA's regulatory and litigation attempts to ban the sale of e-cigarettes that Judge Richard Leon had struck down as illegal just three weeks prior to Tom's press announcement). Some of the claims made in Tom's videotapes were reprinted in the VCU press release.

Study Reveals a Need to Evaluate and Regulate 'Electronic Cigarettes'
“Electronic cigarettes” fail to deliver nicotine
2/10/2010
Study Reveals a Need to Evaluate and Regulate 'Electronic Cigarettes' – VCU News Center

Electronic cigarettes should be evaluated, regulated, labeled and packaged in a manner consistent with cartridge content and product effect – even if that effect is a total failure to deliver nicotine as demonstrated in a study supported by the National Cancer Institute and led by a Virginia Commonwealth University researcher.

and

“Consumers have a right to expect that products marketed to deliver a drug will work safely and as promised. Our findings demonstrate that the ‘electronic cigarettes’ that we tested do not deliver the drug they are supposed to deliver. It’s not just that they delivered less nicotine than a cigarette. Rather, they delivered no measurable nicotine at all. In terms of nicotine delivery, these products were as effective as puffing from an unlit cigarette,” said principal investigator Thomas Eissenberg, Ph.D., professor in the VCU Department of Psychology.

According to Eissenberg, these findings are important because they demonstrate why regulation of these products is essential for protecting the welfare and rights of consumers. With regulation, consumers can expect that these and similar products will be evaluated objectively and then labeled and packaged in a manner that is consistent with the drug they contain and the effects they produce, he said.

“Regulation can protect consumers from unsafe and ineffective products, but these products have somehow avoided regulation thus far. Our results suggest that consumers interested in safe and effective nicotine delivery need to be very wary of unregulated “electronic cigarettes,” said Eissenberg.

But since VCU's press office sent the press release to CNN (and probably many other news media outlets) several days before it appeared on VCU's website (which is referred to as a news embargo, a tactic done to increase chances of generating news), CNN went public with its story (to beat competitor news outlets) on 2/8/10 at


Study: 'Electronic cigarettes' don't deliver - CNN.com

that contained the following excerpts

"Electronic cigarettes" that vaporize nicotine juice to inhale instead of smoke from burning tobacco do not deliver as promised, according to research at Virginia Commonwealth University.

"They are as effective at nicotine delivery as puffing on an unlit cigarette," said Dr. Thomas Eissenberg, at the school's Institute for Drug and Alcohol Studies.

and

The latest clinical evidence suggests users are not getting the addictive substance they get from smoking tobacco. "These e-cigs do not deliver nicotine," Eissenberg said of the findings he expects to publish in an upcoming issue of the British Medical Journal.

 

[teissenb]

For the record, I have never conducted a "press conference" in my life, at least as I understand the term "press conference" (e.g., "a media event in which newsmakers invite journalists to hear them speak and, most often, ask questions."). I got that quotation from wikipedia, the first hit when I googled "press conference".

VCU did not violate an embargo. The CNN reporter "misunderstood the publishing timetable" (that quotation is from an e-mail I am looking at right now, it is from the CNN reporter in question, and it is dated "02.09.2010 10:30"). In fact, VCU was chagrined to be scooped by CNN and the VCU press office waited patiently for permission from Tobacco Control to post the press release and video clips. I also have e-mails from the Journal's editor to document this fact.

As I wrote elsewhere on this forum only four days ago:

"I stand by the results reported in the Eissenberg (2010) Tobacco Control letter and the Vansickel et al (2010) CEBP paper, keeping in mind, of course, that (as noted in both publications) the data are limited to the products tested and the conditions described."

So for example, the quotation "'These e-cigs do not deliver nicotine,' Eissenberg said of the findings he expects to publish in an upcoming issue ...." is exactly accurate. In that paper we demonstrated that "these e-cigs" (the ones we tested) do not deliver nicotine (under the conditions described in the published Tobacco Control paper).

Mr. Godshall's vigorous and rarely factual attacks on me and my work are unwarranted and unwelcome. I ask that he stop. I won't respond to any comments of his in the future except to repeat these three sentences.

Tom E.

 

[Bill Godshall]

The only reason why CNN titled its article
Study: 'Electronic cigarettes' don't deliver
was because Tom's/VCU's press release was titled
Study Reveals a Need to Evaluate and Regulate 'Electronic Cigarettes'
“Electronic cigarettes” fail to deliver nicotine

But I understand that communication errors can occur with the news media (especially when press releases contain exaggerated headlines), which is why I and others repeatedly urged Tom to issue a correction to the news media (after Tom claimed that the media misrepresented his statements and after Tom acknowledged that e-cigarettes can indeed emit nicotine at http://www.e-cigarette-forum.com/forum/e-cigarette-news/69409-cnn-com-today-69.html)

But since Tom refused to issue a correction to the news media, subsequent news articles repeated Tom's headlines that e-cigarette emit no nicotine, and repeated Tom's fearmongering claims about e-cigarettes. Nearly a year later, the following article appeared.

A safe alternative, or a risky experiment?
Electronic cigarettes gaining in popularity, but some doctors caution patients not to use them.Fredricksburg.com (1/20/11)
Fredericksburg.com - A safe alternative, or a risky experiment?

The bottom line, according to Eissenberg: "We don't have the data to believe they are safe, and we don't have the data to believe they are not. This is not the kind of wait-and-see experiment I want to see the American people participate in."

And several months later, the following article appeared.

Studies find electric cigarettes claims do not add up (WNDU 4/3/11)
Studies find electric cigarettes claims do not add up

"We wanted to know if they really delivered nicotine," said Eiseenberg. "One of the things they're supposed to do. If they really produce some of the same effects as a tobacco cigarette."

A pair of studies conducted by VCU discovered that while real cigarettes deliver nicotine, electronic-cigarettes do not despite claiming to do so.

"Neither of them delivered nicotine," said Eissenberg. "Which was surprising because that is, in fact, exactly what they are supposed to do."

Although I'm pleased that Tom eventually (several months ago) notified other tobacco/nicotine researchers and ECF readers that he subsequently found that e-cigarettes do deliver nicotine, I'm still not aware that he has notified the news media (that e-cigarettes emit nicotine).

Since the new Vansickle/Weaver/Eissenberg article is far superior to original letter they sent to Tobacco Control in 2010 (for which they issued the "e-cigarettes emit no nicotine" press release), I encourage Tom and VCU to issue a press release citing their new findings.


On another far more important issue, I'm not aware that Tom has rescinded or clarified his past advocacy urging the FDA to regulate (i.e. ban) the sale of e-cigarettes. Thus, I can only conclude that Tom still wants the FDA to deny all e-cigarette consumers (and 45 million cigarette smokers) in the US of legal access to e-cigarettes.

Perhaps Tom can explain if and why he still supports e-cigarette prohibiton, or if he's changed his mind and now supports keeping the sale of e-cigarettes legal in the US (as that's the primary concern of mine and many ECF readers).

 

[rolygate]

It appears that the relevant facts regarding the previous clinical trial have been clearly stated by both parties, according to their view of events, and the difference of opinion has been adequately presented. This is one of those occasions where no convergence of opinion is likely.

Therefore can I ask that discussion of this topic ceases. Further posts on this subject will be deleted or edited. Members should restrict their comments to the topic noted in the thread title, please.

Thank you.

 

[Vocalek]

I found this to be a most positive study. The question of abuse potential will no doubt be brought up by those hoping to regulate the products.

 

[Tom09]

It’s good to see that another formally published study contributed to the growing scientific body on electronic cigarettes. The abstract reads nothing but factual, and I also think that it is a positive finding for proponents that e-cigs “ appear to have lower potential for abuse relative to traditional tobacco cigarettes”.

 

[CJsKee]

Very glad to see a positive scientific study! I just don't understand why they offered "varying amounts of money." Does it somehow have to do with "abuse potential?" Could someone explain?

 

[Thulium]

Very glad to see a positive scientific study! I just don't understand why they offered "varying amounts of money." Does it somehow have to do with "abuse potential?" Could someone explain?

It's a way to objectively measure "addictiveness": the more money it takes for a subject to choose money over taking 10 puffs, the more addicted they are assumed to be. It took significantly more money to convince someone to give up 10 puffs from their "own brand" than to sacrifice 10 puffs from the e-cig they tested.

 

[rolygate]

It's a bit like if they tested me with how much money it would take to get me to take the cash instead of my morning cup of tea. It would be at least $2,000 - maybe more. That or I would kill the researcher.

So I guess that makes me a hopeless tea addict who should be placed in a secure unit for treatment due to the problems I may cause myself and society. Does the FDA regulate tea? Is there a Chantix for tea?

 

[rothenbj]

I don't want to get OT on this, but one of Tom's statements just gnaws at me.

In fact, VCU was chagrined to be scooped by CNN and the VCU press office waited patiently for permission from Tobacco Control to post the press release and video clips.

Does this mean any research done needs to get permission from Tobacco Control to be released to the public? As a follow up, who runs Tobacco Control?

 

[rolygate]

What he is referring to is an embargo on publication before a specific date/time, which is common among those sending out a press release to many different publications, some of whom may want to research some details and have an article ready at the given time. One or two days in advance of the authorised publication date is common.

This is a standard procedure and suits everyone. Some publications however publish ahead of time in order to scoop their rivals. They gamble that they are so big they will still get the material next time, as the author needs them. Or, that this is a good story and the source won't produce anything on this scale again, so even if they are dropped from the press release list, it doesn't matter.

Everyone needs the media but they are not ideal partners.

 

[rothenbj]

Thanks for the clarification Chris.

 

[rolygate]

As regards tobacco control, it's split into various factions, like everything. It seems that the largest group by far receive a significant amount of funding from the pharmaceutical industry, which may influence their opinions; and they are also jealous in maintaining control of what they regard as their domain. Interlopers with a different agenda are not welcome.

A mass reduction in the smoking death rate, for example, is not good news if your job depends on large numbers of people dying and thus creating an environment where funding is easy to come by.

For example if cash is so easy to get hold of that you can obtain $850,000 for watching YouTube videos, it can be imagined that should a situation arise where there is no need for tobacco control researchers in the present numbers, such easy money would dry up. Snus and e-cigarettes are the tobacco control industry's worst nightmare, since if the death rate falls even more than the 40% it did in Sweden - which is quite likely with e-cigarettes - many of their jobs will disappear, since in effect they will have become irrelevant.

 

[Vocalek]

I believe Eissenberg was referring to the scientific journal named Tobacco Control, not to the group of people working to denormalize smokers and other tobacco users.