Wednesday, May 30, 2018

Smoking Cessation Clinical Trials…and Tribulations


The medical establishment has transformed a behavior, cigarette smoking, into a disease, and now defines how smoking should be “treated” and “cured”.

The ramifications of this scheme were laid bare last week in a New England Journal of Medicine report on a smoking cessation clinical trial (here).  The article, “A Pragmatic Trial of E-Cigarettes, Incentives, and Drugs for Smoking Cessation,” demonstrated one important fact:

Clinical trials are awful for assessing human behaviors and preferences like smoking.

The authors, mostly from the University of Pennsylvania, enrolled 6,006 smokers employed at 54 companies and gave them “usual care”, consisting of wellness website links and information about the National Cancer Institute’s free text-messaging program, plus one of four “treatments”:

1.     Free medicines, including nicotine, bupropion and varenicline, plus free e-cigarettes “if standard therapies failed;”
2.     Free NJOY e-cigarettes;
3.     A reward of up to $600 if smokers stayed abstinent, plus number 2 above; or,
4.     A deposit account up to $600, plus number 2 above.

Here are the results:


“Treatment” Groups and Successful Quitting at 6 Months
Treatment (number)Number (%) of Successful Quitters


Usual Care (813)1 (0.1%)
Free Medicines (1,588)8 (0.5%)
Free E-cigarettes (1,199)12 (1.0%)
$600 Reward (1,198)24 (2.0%)
$600 Deposit (1,208)35 (2.9%)


All (6,006)80 (1.3%)

In all, only 1.3% of smokers quit, ranging from 0.1% with usual care, to 2-3% for those given financial incentives.  In the study, which lasted only six months, the best “treatment” had a 97% failure rate.  After a full year, the standard period for such trials, one could expect percentages to be even lower. 

While the futility of using clinical trials to gauge smoking cessation has been demonstrated repeatedly, medical research and regulatory authorities still demand clinical trial proof – the medical treatment standard – for the benefits of switching from combustible cigarettes to smoke-free products. 

Just as common sense tells us that a hammer can’t be used to fasten a screw, the medical community should acknowledge that clinical trials can’t be used to assess smoking cessation. The reason is simple: smoking is not a disease.  Most smokers don’t want treatment, cure, nagging or ostracism. They want information about the full suite of their options, including abstinence and all forms of tobacco harm reduction.  

In publishing this uninformed study, The New England Journal of Medicine’s authors and editors demonstrate that the illness-treatment-cure model of smoking is erroneous and completely uninformative.  The medical/public health community needs to embrace population evidence from the FDA survey proving that smokers are quitting with e-cigarettes (here).


Thursday, May 24, 2018

Kentucky Adopts a Rational Tobacco Tax Plan


Last month, the Kentucky legislature overrode Governor Matt Bevin’s veto and passed HB366 (here), a tax reform bill that increased cigarette excise taxes from $0.60 to $1.10, while leaving taxes on smokeless products unchanged and leaving e-cigarettes with no excise tax.

This policy mirrors the tax plan that my research group designed (here) – one endorsed by 16 tobacco research and economic policy experts from across the nation, and by the Pegasus Institute (here).  Watch my interview with Nick Storm of Spectrum News here to learn more.

Enacting this plan, legislators rejected demands from anti-tobacco crusaders to double the cigarette tax increase and make vastly safer smokeless and e-cigarettes equally expensive.  One of their spokesmen, Foundation for a Healthy Kentucky president Ben Chandler, had argued, “you’ve got to have the sticker shock…” (here)

That reasoning is both insensitive and nonsensical.  Many Kentucky smokers are unable or unwilling to quit tobacco and nicotine entirely.  For them, traditional quit-smoking methods, which strive for nicotine and tobacco abstinence, don’t work. 

Our tax plan encourages and incentivizes smokers to quit or switch to less expensive and vastly safer smoke-free tobacco products, including smokeless tobacco and e-cigarettes. 

Decades of epidemiologic studies document that the health risks of dipping and chewing tobacco are, at most, a mere two percent of those associated with smoking.  Unlike cigarettes, smokeless tobacco does not cause lung cancer, heart and circulatory diseases or emphysema.  A recent study conducted by federal researchers and experienced epidemiologists found that men who dip or chew tobacco have no excess risk for mouth cancer (here).    

Our plan also encourages smokers to switch to e-cigarettes, which already are among the most common – and most successful – quit aids in the U.S. (here). 

HB366 contains another provision favoring reduced risk products.  Kentucky excise taxes will be reduced by half for products that are permitted by the FDA to be marketed as “lower risk.” 

Reduced risk applications have already been filed with the FDA for three products: IQOS heat sticks, Camel Snus and Copenhagen moist snuff.  Science tells us that all of these are vastly safer than cigarettes.  The question is: When will the FDA acknowledge this indisputable fact?


Thursday, May 17, 2018

Tobacco Research Is Not Immune to Scientific Scrutiny


Recently, the authors of a research article on e-cigarettes groundlessly attacked my credentials and academic independence after I noted, in a letter to journal editors, a lack of scientific rigor in their reporting. The article falsely claimed that e-cigarette use caused experimental smokers to become regular smokers.  In response to my critical remarks, the authors made these charges in their own letter to the editors: “This recent comment is another in a long series of letters or comments from Dr. Rodu…in which he has criticized research that is inconsistent with the tobacco industry’s interests in promoting e-cigarettes and smokeless tobacco.”

As an academician, I have both authored articles and scrutinized tobacco research for many years, advising journal editors on those occasions when I found factual deficiencies in published articles.  This effort has served the interests of science and the pursuit of truth.

Professional medical journals position themselves as platforms for the publication of honest, transparent, reproducible research.  In an effort to identify inaccuracies and other defects, submissions are subjected to review by editors and multiple external authorities who are experts in relevant fields.

Over the last 24 years, in addition to my authorship of 54 peer-reviewed articles for medical and scientific journals (here), I have had 11 letters of scientific criticism published in leading journals, linked below.               

1.  Rodu B, Cole P.  Excess Mortality in Smokeless Tobacco Users Not Meaningful.  American Journal of Public Health 85:118, 1995.

2. Rodu B, Cole P. Smokeless Tobacco and Periodontal Disease. Letters to the Editor. Journal of Dental Research 84:1086-1088, 2005.

3. Rodu B, Cole P. A deficient study of smokeless tobacco use and cancer (letter).  International Journal of Cancer 118: 1585, 2005.

4. Rodu B. Snus and the risk of cancer of the mouth, lung, and pancreas.  Lancet 370: 1207, 2007.

5. Rodu B.  Smokeless tobacco: Society response debatable (electronic letter).  CA: A Cancer Journal for Clinicians 2008; 58. 

6. Rodu B, Heavner KK.  Errors and omissions in the study of snuff use and hypertension (letter).  Journal of Internal Medicine 265: 507-8, 2009.

7. Rodu B, Heavner KK, Phillips CV.  Snuff use and stroke (letter).  Epidemiology 20: 468-9, 2009.

8. Rodu B.  Dual use (letter).  Nicotine & Tobacco Research 13: 221, 2011.

9. Rodu B, Plurphanswat N, Phillips CV.  Discrepant results for smoking and cessation among electronic cigarette users (letter).  Cancer 2015 Mar 4. doi: 10.1002/cncr.29307. [Epub ahead of print]

10. Rodu B, Phillips CV.  Regarding “Discontinuation of Smokeless Tobacco and Mortality Risk after Myocardial Infarction” (letter).  Circulation 2015 Apr 28;131(17):e422. doi: 10.1161/CIRCULATIONAHA.114.012038.

11. Rodu B.  Re: Smokeless tobacco use and the risk of head and neck cancer: pooled analysis of US studies in the INHANCE consortium.  American Journal of Epidemiology 2017  DOI: 10.1093/aje/kwx211

All scientific research should be subjected to rigorous objective review. On those occasions when pre-publication editorial and peer review fail to identify deficiencies, honest criticism should be encouraged and acknowledged by offending publications.