Thursday, March 27, 2014

Smoking Cessation Expert to Health Canada: Stop Killing Smokers

Health Canada has blocked sales of nicotine-containing e-cigarette sales, even though the devices are readily available in the U.S.  I previously commented on the agency’s unfounded opposition to tobacco harm reduction (here). 

This week, Dr. Gaston Ostiguy, medical director at the Montreal Chest Institute’s Smoking Cessation Clinic, told Health Canada, “It’s time to authorize the sale of electronic cigarettes.”  His stern admonition, published as an open letter in the Montreal Gazette (here), was co-authored by tobacco research and policy experts from Canada, Switzerland, Italy and the United Kingdom.

Dr. Ostiguy objected to the general obsession with tobacco prohibition: “Unfortunately, it is wishful thinking that one day we will completely eradicate nicotine use.”  He referenced a report that I have often cited in my lectures and blog posts: “In a landmark report published in 2007, the Royal College of Physicians makes a compelling case why harm reduction should no longer be ignored by health authorities to lower the death and disease caused by tobacco use.”

Dr. Ostiguy summarized the Royal College’s findings:  

·       Conventional prevention and cessation “will be ineffective for the millions of smokers who, despite best efforts to persuade and help them to quit, will carry on smoking.

·       “Tobacco-control policy needs to be radically extended to address the needs of these smokers with implementation of effective harm reduction strategies.
·       “Harm reduction in smoking can be achieved by providing smokers with safer sources of nicotine that are acceptable, and effective cigarette substitutes.
·       “There is a moral and ethical duty to provide these products to addicted smokers.”

The bottom line:

·       “Electronic cigarettes are such a substitute.”

Dr. Ostiguy noted e-cigarettes’ significant harm reduction benefits and their potential, but unproven, risks.  He called on Health Canada to establish appropriate regulation “so that good manufacturing practices are followed to protect consumers and that sales to minors are forbidden. However, any excessive regulations that could make it too difficult to communicate about the reduced risks of these products or to access them should be avoided.”

That is a message for FDA regulators, as well.

Thursday, March 20, 2014

Clinical Trial: E-Cigarettes Are Satisfying Cigarette Substitutes

A clinical trial demonstrates that e-cigarettes deliver nicotine, reduce craving and satisfy vapers. The research, published in Scientific Reports (here), is the work of Konstantinos Farsalinos and colleagues at the Onassis Cardiac Surgery Center in Kallithea Greece.

Twenty-three experienced vapers (all former smokers) were recruited to compare a small e-cigarette (V2, also called a ciga-like) with a more advanced and powerful model (EVIC) in a cross-over trial on two separate days.  Participants abstained from e-cigarettes, caffeine and alcohol for eight hours before each session.  In the sessions, vapers took 10 puffs during the first 5 minutes, then puffed ad lib for the next hour.

The advanced e-cigarette models delivered about 50-70% more nicotine than ciga-likes throughout the trial.  Peak blood nicotine levels, occurring at the end of the session, were 23 nanograms per ml for the advanced model and 16 ng./ml for the ciga-likes. 

The investigators also compared nicotine delivery from these devices to previously published levels from conventional cigarettes.  They concluded, “…it took about 35 minutes of vaping with the [advanced] device at high wattage in order to obtain plasma levels similar to smoking one cigarette in 5 minutes.  The [ciga-like] was even less efficient in nicotine delivery; even 65 minutes of ad lib vaping (sic) was insufficient to deliver…nicotine at levels similar to smoking.”

The difference in nicotine delivery may have accounted for the fact that the advanced devices reduced cravings to a significantly lower level than ciga-likes during the sessions.  Vapers rated the advanced devices as significantly more satisfying and more likely to provide a “throat hit,” even though they produced significantly more throat burning.  They rated ciga-likes as more similar to a cigarette.  There were no differences in other effects, such as calming, concentration or taste.

The bottom line: E-cigarettes are satisfying cigarette substitutes.  Ciga-likes have the look and feel of traditional cigarettes, while advanced models deliver nicotine and tobacco satisfaction more efficiently.  The findings suggest that the current e-cigarette market provides a range of models that should appeal to the majority of smokers.

Thursday, March 13, 2014

Vapers, Know Your E-Cig Ingredients: Propylene Glycol

A common knock against e-cigarettes is that we don’t know the long-term health effects of consuming nicotine vapor.  The fact is that while it’s impossible to have complete knowledge about a novel form of tobacco use, scientists already know a great deal about propylene glycol (PG), a key ingredient of the vapor in e-cigarettes.

A comprehensive 2012 PG toxicology review, authored by members of the Cosmetics Ingredient Review (CIR) expert panel, appeared in the International Journal of Toxicology (available here). 

The report was an update of a 1994 assessment which concluded that PG was “safe for use in cosmetic products at concentrations up to 50.0%” – the cosmetic industry standard at the time.    By 2012, PG was used in 9,094 of 34,391 cosmetic and personal care formulations.  One of the most interesting passages in the 1994 document was a description of aerosolized PG in hair sprays:

“Propylene glycol is used in hair sprays, and its effects on the lungs that may be induced by aerosolized products containing this ingredient may be of concern.  The aerosol properties that determine deposition in the respiratory system are particle size and density.  The parameter most closely associated with deposition is the aerodynamic diameter, da, defined as the diameter of a sphere of unit density possessing the same terminal settling velocity as the particle in question.  In humans, particles with an aerodynamic diameter of < 10 um [micrometers] are respirable.  Particles with a da from 0.1 to 10 um settle in the upper respiratory tract and particles with a da < 0.1 um settle in the lower respiratory tract.  Particle diameters of 60 to 80 um and > 80 um have been reported for anhydrous hair sprays and pump hairsprays, respectively.  In practice, aerosols
should have at least 99% of their particle diameters in the 10 to 110 um range and the mean particle diameter in a typical aerosol spray has been reported as ~ 38 um.  Therefore, most
aerosol particles are deposited in the nasopharyngeal region and are not respirable.”

In contrast, PG aerosols generated by e-cigarettes appear to be smaller, in the range of 0.1 to 0.4 um, according to a study published last year (abstract here).  So, while it likely that most e-cigarette vapor is settling in the upper respiratory tract, some small aerosol particles are likely reaching deeper lung tissue. 

The 2012 CIR panel also commented about PG as a food additive: “According to the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the acceptable daily intake of PG is 25 milligrams per kilogram of body weight per day.  In Japan, the Ministry of Health, Labour, and Welfare (MHLW) specified that according to the food sanitation law, PG has no potential to cause harm to human health.”

The CIR panel also reviewed numerous animal studies regarding potential problems.  They concluded: “Both PG and PPGs [polypropylene glycols] were not considered to be acute or
chronic toxicants in oral or dermal studies, were not genotoxic or carcinogenic, and were not reproductive or developmental toxicants, supporting that their use in cosmetics would be safe
in regard to these end points.”   

The CIR was established in 1976 by an industry association with the support of the FDA and the Consumer Federation of America; it reviews and assesses the safety of ingredients used in cosmetics.  University faculty, industry representatives and the director of the Office of Cosmetics and Colors at the FDA participate in the reviews, which are conducted according to published procedures (here).  The CIR appears to be an excellent example of cooperation between federal regulators and the industry they regulate; it might serve as a template for cooperation among the FDA Center for Tobacco Products and tobacco manufacturers. 

The FDA has thus far taken an aggressively antagonistic approach in its regulatory procedures, some of which are dictated by the 2009 enabling legislation.  For example, the legislation prohibits members of the FDA Tobacco Product Scientific Advisory Committee (TPSAC) from having any relationship with the tobacco industry in the 18 months preceding their appointment (documented here).  This is in direct contrast to all other federal advisory committees (including expert CIR panels), in which an industry conflict of interest for a qualified candidate is reportable but not prohibited.

The CIR served the public interest in producing an informative PG safety review; it also serves as a role model for constructive government-industry interaction.

Friday, March 7, 2014

UCSF Study Falsely Links E-Cigarettes to Smoking

Academics at the University of California San Francisco have used the 2011 and 2012 National Youth Tobacco Survey to fabricate a claim that “e-cigarettes are likely to be gateway devices for nicotine addiction among youth, opening up a whole new market for tobacco.”  Lead author Lauren Dutra provided that quote to the media in a UCSF press release touting the study (here).  Dr. Stanton Glantz was a coauthor.  The study appears in the Journal of the American Medical Association Pediatrics.

The UCSF press release also contains a demonstrably false leading statement: “The study of nearly 40,000 youth around the country also found that e-cigarette use among middle and high school students doubled between 2011 and 2012, from 3.1 percent to 6.5 percent.”

These percentages DO NOT refer to current e-cigarette use, but to ever e-cigarette use, “even just one time.”  I have analyzed this data before (here and here).  E-cigarette use among middle and high school students did double between 2011 and 2012, from 1.0 to 2.0 percent.  The chart on the left provides a truthful picture of e-cigarette use.
The Dutra-Glantz study consisted of a dizzying array of statistical analyses that could not possibly support their claim that e-cigarettes are a gateway to cigarettes.  Unfortunately, the media is headlining this false claim around the globe. 

The only positive note in this otherwise dark story is that, for the first time, Dr. Glantz’s fabrication was called out by the American Cancer Society and the American Legacy Foundation.  The ACS’s Dr. Thomas Glynn said in the New York Times, “The data in this study do not allow many of the broad conclusions that it draws.” (here). 

Dr. David Abrams of the American Legacy Foundation confirmed that the data do not support the authors’ conclusion.  “I am quite certain that a survey would find that people who have used nicotine gum are much more likely to be smokers and to have trouble quitting, but that does not mean that gum is a gateway to smoking or makes it harder to quit,”

There is more.  My chart shows that although e-cigarette use increased, exclusive cigarette smoking plummeted, from 4% to 2.8% among middle school students, and from 14.6% to 11.8% among high school students.  This dramatic decline further undermines Dutra-Glantz’s claims.

Anti-tobacco extremists have won this media skirmish against e-cigarettes, but at a price – their integrity.