Dr. Bertollini of the WHO on twitter - my response

[Oliver]

Dr. Bertollini engaged in some near-conversation with vapers yesterday. This is a first for a man with a real propensity to instantly blocking dissenters.

Anyway, the upshot was that he appeared to indicate that he might enter into dialog as to why he believes Dr. Polosa's e-cigarette efficacy study is floored, given the appropriate venue.

I decided I'd get the ball rolling and wrote up my response here: A plea to Tobacco Control - do not disregard this important research - ECF InfoZone

Somehow I think this is a bit of a quixotic task, but I thought I'd give it a go.

 

[e-pipeman]

A solid piece SJ. Will you please post here if Dr Bertollini responds?

 

[the_vape_nerd]

Extremely well written, I will be hoping and looking for his reply.

 

[AgentAnia]

This is the clearest explanation of the "lost to followup" figure and how it should figure in final analyses in these studies (and a very enlightening comparison to a similar issue in the tobacco Control report!)

Looks like Dr. Bertollini cherrypicks with the best of 'em!

Looking forward to his reply.

 

[Oliver]

Yes, E-Pipeman, I certainly will. Don't hold your breath, though.

 

[e-pipeman]

Yes, E-Pipeman, I certainly will. Don't hold your breath, though.

I await his comments with interest.

 

[Oliver]

Let's see how long you have to maintain that interest

 

[e-pipeman]

Let's see how long you have to maintain that interest

We all live in hope. Some of you are doing something about it, which I appreciate greatly.

 

[Vocalek]

Dr. Polosa is actually planning on doing something with those "lost to follow-up" folks...which is unheard of in the world of clinical trials sponsored by pharmaceutical companies interested only in getting sufficient data to have their product approved for prescription sale.

And what is really ironic that 70% - 90% failure rates are considered "success" in the world of smoking cessation treatments.

 

[e-pipeman]

That really IS ironic! Good luck to Dr Polosa!

 

[Vocalek]

I left this comment on the "A plea to tobacco Control" page:

So how does this "lost to follow-up" compare with the numbers in clinical trials of FDA (now) approved products? "Within one year, 247 (67%) had follow-up, and 26 (10.5%) maintained abstinence through week 52, 10.2% with varenicline and 10.8% with NRT (p=1.0). Loss to follow-up was 37% for varenicline, 31% for NRT (p=0.20). Including lost patients as smokers, the adjusted quit rates for varenicline and NRT were similar (6.5% vs. 7.6%, p=0.69)." http://www.ncbi.nlm.nih.gov/pu...

I just noticed that the success rate was only ~10% with either varenicline (Chantix/Champix) or NRT at week 52. Dr. Polosa's cohort, specifically selected for having no interest in quitting, showed a similar rate at week 52 among those using the nicotine cartridges.

Edit #2, I just reread and see that the quit rates were only 6.5% and 7.6% when the data was recalculated based on intention-to-treat, which is the method Dr. Polosa used. If you look at the Per Protocol numbers (i.e., those lost to follow up are not counted as failures) quit rates were 20%, 14.3%, and 7.3%, which blows the Chantix / NRT success rates away--and Polosa's subjects were not interested in quitting!

Thanks to Dr. Siegel for posting the quoted paragraph in a Blog post on Monday, July 2, 2012. http://tobaccoanalysis.blogspot.com/2012/07/new-population-based-study-shows-that.html

 

[Oliver]

So, Stanton Glantz has entered the fray, claiming the research can be dismissed on 2 counts:

1. That no control exists, thereby omitting a comparison with those who would have spontaneously quit anyway.
2. That the statistical analysis failed to use a test (Yates) which corrects some assumptions about distribution, and would lead to a non-significant result had it been used.

These arguments have been demolished in short order:

By Dr. Farsalinos - ECLAT study has a control group, Yates correction would be completely inappropriate

By Rory Morrison, Policy & Research Officer, ASH Scotland - TwitLonger — When you talk too much for Twitter

and by Christopher Snowden - http://velvetgloveironfist.blogspot.co.uk/2013/06/glantz-attempts-to-debunk-e-cigarette.html

 

[Spazmelda]

The Snowden discussion is rich. Love the Glantz quotes that show how he flip flops on confidence levels to suit his needs.

 

[e-pipeman]

Mr Bagley's comment on Christopher Snowden's piece is also interesting.

 

[Oliver]

So, things took an interesting turn this morning. Dr. Farsalinos posted his rebuttal to Prof. Glantz's piece in the comments to the Plos One article.

Shortly thereafter, an associate editor took it upon himself to 'oust' Dr. Farlsalinos of not stating his competing interests. Of course, he did no such thing to Prof. Glantz. That is, until I asked him to via twitter.

Anyway, Dr. Farsalinos doesn't have any competing interests according to any sensible definition of the term, and you can see what happened here: PLOS ONE: EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as Tobacco Cigarettes Substitute: A Prospective 12-Month Randomized Control Design Study

Yours truly popped in as well!

 

[Vocalek]

Right now, only S. Glantz comment is posted.

 

[AgentAnia]

Right now, only S. Glantz comment is posted.

I see the comments-posted count as one; all the rest are replies to that one comment.

 

[AgentAnia]

Another good comment on Gl(ANTZ) from D. Puddlecote: http://dickpuddlecote.blogspot.co.uk/

 

[Vocalek]

I left a comment. I can see it, but I'm not sure anyone else can.

PLOS ONE : accelerating the publication of peer-reviewed science

 

[Vocalek]

Another good comment on Gl(ANTZ) from D. Puddlecote: http://dickpuddlecote.blogspot.co.uk/

I find his phrase descriptive phrase "Big Control" quite loverly.