Friday, February 15, 2019

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. 




Sunday, February 10, 2019

TPSAC: Copenhagen Has Lower Lung Cancer Risk




The FDA Tobacco Products Scientific Advisory Committee (TPSAC) met on February 6 and 7  to consider smokeless manufacturers’ advertising and marketing claims that their products are safer than cigarettes (making them modified risk tobacco products, or MRTPs).

Altria, whose U.S. Smokeless Tobacco Company subsidiary sought MRTP status for its Copenhagen snuff product, was the clear winner, as the committee approved the statement, “Switching completely to this product from cigarettes reduces risk of lung cancer.” (here)

Clearly, Altria seeks to underscore the message that their form of smokeless tobacco, which is placed in the mouth and not inhaled, eliminates the risk for lung cancer that is high with cigarette use.  This obvious but important distinction was endorsed 8-0 by the TPSAC panel, with one abstention.

Swedish Match, the other company pursuing an MRTP application (that is now almost five years old), was not as fortunate.  The panel rejected their claim that “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” 

As I commented two months ago, “The term ‘lower risk’ is an understatement, as the risk is almost zero” (here), but the diseases weren’t the problem.  Some TPSAC members thought that approval would send the message to kids that snus was “safe.”  Brian King, a deputy director at the CDC Office on Smoking and Health, expressed concern about future unknowns: “…just because [snus usage] is low now we have to completely dismiss what the relevance could be in the future.” he said. “My response to that is one word: Juul.” (here)

King also said that Swedish Match’s “continued absence of any youth data is preposterous to me.”  He seemed to be faulting the company for not surveying teens about snus products, even though, as the company pointed out, such research could run afoul of a ban on teen marketing. 

Panel member Ken Warner supported the Swedish Match application.  “I think the health (benefits) are really clear compared to smoking -- more so than for any other smokeless tobacco product.  My sense is that if this is not approved, it might be the death knell for the [MRTP] process because we would be basically saying you can't get anything through this process.”