Don't 'Narrow The Off-Ramp' For Smokers Who Want to Quit

On February 13 the Washington Examiner ran my commentary on the FDA Commissioner Scott Gottlieb’s vow to “narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs,” which would be a deadly mistake for many smokers.  Read the article on the Examiner website (here) and below.

Smokers need all the help they can get to quit cigarettes. New research reported in the prestigious New England Journal of Medicine (NEJM) confirms that e-cigarettes are significantly more effective than FDA-approved nicotine medicines in helping smokers end their deadly habit.

This study is impressive proof of the scientific concept known as tobacco harm reduction, the substitution of vastly safer smoke-free tobacco products – e-cigarettes and smokeless tobacco – by smokers who are unable or unwilling to become nicotine and tobacco abstinent.  Decades of scientific studies document that dipping and chewing tobacco are 98 percent safer than inhaling smoke (here, here, here, here, here), and the prestigious British Royal College of Physicians observed that “vapour inhalation from the e-cigarettes available today is unlikely to exceed 5% of the harm from smoking tobacco.” (here). 

The NEJM article describes a British clinical trial in which 886 smokers were given either a refillable e-cigarette and one bottle of liquid, or nicotine medicines (pill, gum or patch).  E-cigarette users were encouraged to experiment with liquids of different strengths and flavors.  Nicotine users selected their preferred products and they were allowed to use them in combination and to switch them up as desired. 

After one year, 18 percent of those in the e-cigarette group were not smoking, compared with 9.9 percent in the nicotine medicine group.  That is, e-cigarette users were twice as likely to quit than nicotine medicine users.  Another 13 percent of e-cigarette users reduced their smoking by at least 50 percent, compared to only 7 percent of nicotine medicine users. 

This study confirms the results of earlier, smaller clinical trials in Italy (here and here), New Zealand (here) and Greece (here).  More importantly, it addresses the demand of tobacco control activists for blue ribbon scientific proof.  Among that group are regulators in the FDA.  That agency’s historic mission has been to judge the effectiveness of medicines before making them available to the public.  Their primary assessment tool is the clinical trial – a highly sophisticated and costly experiment, in which doctors control the source and dosing of the medicine and all aspects of patient care.

Until now, doctors have considered smoking a disease, to be treated with nicotine medicines, anti-depressives, nicotine blocking agents (like varenicline), and behavioral counseling.  Clinical trials were used to validate such regimens, and success rates have been abysmally low.     

Today, e-cigarettes are upsetting the clinical trial cart.  As consumer products, they are widely available to millions of smokers, making it extremely difficult, if not impossible, to conduct controlled clinical trials (here).  Consumers, not doctors, are making the decisions in this environment.  Instead of clinical trials, the best evidence for consumer e-cigarette behavior can be gleaned from surveys.  

My university research group’s analysis of government survey data shows that e-cigarettes were among the most commonly used quit aids by American smokers in 2013-2014, and they were the only aid more likely to make one a successful quitter than quitting cold-turkey (here).  Other studies in the U.S. and the United Kingdom have reported similar results, and together provide population-level, real world proof that smokers are quitting with e-cigarettes (here).

 

In the UK, government officials and most medical societies encourage smokers to switch to vastly safer cigarette alternatives.  It’s time for their U.S. counterparts to provide American smokers with the same lifesaving options (here).  The new British study adds to the argument against FDA Commissioner Scott Gottlieb’s vow to “narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs.”  That would be a deadly mistake for many smokers. 

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).

E-Cigarettes = Nicotine Patches for Smoking Cessation, Clinical Trial Shows

Newly published research shows that e-cigarettes are about as effective as nicotine patches in helping smokers quit. That should (but won’t) silence critics who insist that e-cigarettes are unproven and that medicinal nicotine products are the only scientifically valid cessation aids.

At New Zealand’s University of Auckland, Dr. Christopher Bullen and colleagues compared quit rates among 657 smokers treated for 12 weeks with nicotine e-cigarettes, nicotine-free e-cigarettes, or 21-mg. nicotine patches.  Their randomized study was published in the Lancet (abstract here).   

Bullen and colleagues reported continuous abstinence from smoking at 1, 3 and 6 months after the participants’ quit day.  Here is a summary of the main results:

Continuous Smoking Abstinence (%) Among Smokers Treated With Nicotine E-cigarettes, Nicotine-Free E-cigarettes and Nicotine Patches
Follow-Up (months)	Nicotine E-cigarettes	Nicotine-free E-cigarettes	Nicotine Patches
1	23	16	16
3	13	6.8	9.2
6	7.3	4.1	5.8

There were no significant differences between any of the treatments in any time period.  In other words, e-cigarettes were just as effective as nicotine patches in helping smokers quit – keeping in mind that “effective” here is only a roughly seven percent quit rate (here).  At one-year follow-up, the gold standard for cessation trials, the results would be even worse. 

This new study adds to a growing body of evidence supporting the effectiveness of e-cigarettes (here, here, and here).

A seven-percent solution is not very impressive, but if the real objective is to improve the health of smokers, the products might not be the problem.  Rather, fault may lie with the clinical trial model, in which smoking is the “illness,” 12 weeks of NRT or e-cigarettes or snus is the “therapy,” and nicotine/tobacco abstinence is the only targeted “outcome.”  Most people consider smoking a lifestyle choice, not an illness; they aren’t seeking treatment, and they are unwilling or unable to abstain.  The biggest challenge, therefore, isn’t to offer more quitting options, it is to alter the design of clinical trials to accommodate smokers’ preferences and incorporate the principles of tobacco harm reduction.  Changing the targeted outcome from nicotine/tobacco abstinence to smoking abstinence would permit ex-smokers to use alternative products at satisfying doses, indefinitely if they choose.   

Blocking the path to accomplishing this smoke-free objective is the bizarre demand by tobacco-prohibitionists that companies seeking FDA approval for harm reduction products must first prove that they will not cause population-level effects (discussed here).  Peter Hajek addressed this challenge in a Lancet commentary accompanying the Bullen study: “There is an obvious source of evidence as to whether use of e-cigarettes leads to an increase or reduction in tobacco smoking: the trajectories of sales of e-cigarettes and tobacco cigarettes.  If growing sales of e-cigarettes coincide with increased sales of tobacco cigarettes, tobacco control activists arguing for restriction of e-cigarette availability would be vindicated.  If traditional cigarette sales decline as e-cigarette sales increase, it would suggest that e-cigarettes are normalising non-smoking and that it is in the interest of public health to promote and support their development rather than try to restrict it.”

Hajek makes a legitimate case for using market data as the primary indicator of e-cigarettes’ public health impact.  An accelerating decline in cigarette consumption will confirm the positive public health impact of an e-cigarette revolution.