Thursday, May 23, 2013

Trace Metals in E-Cigarettes: No Cause for Concern



I have discussed a study reporting that smokeless tobacco contains trace levels of several metals, including cadmium, arsenic, nickel, chromium and lead (here).  Now researchers at the University of California, Riverside, report that the aerosol from an undisclosed e-cigarette contained numerous metals.

The study, whose lead author is Monique Williams, appears in PLoS One (here). It notes, “A total of 22 elements were identified in EC [electronic cigarette] aerosol, and three of these elements (lead, nickel, and chromium) appear on the FDA's ‘harmful and potentially harmful chemicals’ list.  Lead and chromium concentrations in EC aerosols were within the range of conventional cigarettes, while nickel was about 2–100 times higher in concentration in EC aerosol than in Marlboro brand cigarettes.”

The article implies that e-cigarettes are the source of inhaled toxic metals.  But, as pointed out previously by Boston University’s Michael Siegel (here), the amount of metals delivered to e-cigarette users is lower than the daily exposures permitted by the authoritative US Pharmacopeial Convention (USP) for inhalable medications.

Williams and colleagues reported that 10 aerosol puffs, the equivalent of one cigarette, contained 0.017 micrograms (ug, one-millionth of a gram) of lead.  This means that a pack-a-day equivalent (200 puffs) contains 0.34 ug of lead.  According to the USP (here), it is permissible for an inhaled medication to deliver up to 5 ug of lead per day to a 50 kilogram (~ 100 pound) person. 

The same holds true for nickel, chromium and copper.  For nickel, Williams reported the pack-a-day e-cigarette level at 0.1 ug, while the USP allows 1.5 ug per day in inhaled medicines.  For chromium, Williams reported that e-cigarettes deliver 0.14 ug, while the USP allows 25 ug in inhaled medicines.  For copper, the Williams-reported level is 4.06 ug; the USP allows 100 ug.  

Tin is another metal Williams reported in e-cigarette vapor, at 0.74 ug per 200 puffs. The CDC reports (here) that the average U.S. daily intake of tin by inhalation is 3 ug.  

To be clear, the problem with the Williams study is not that it reported trace concentrations of metals in e-cigarette vapor.  That is useful information.  The problem with this study, as with most works of this kind in the past 20 years, is that it was published without context.  As the above quote shows, e-cigarettes were compared to traditional cigarettes without any reference to exposure from other inhalation settings and/or products.  

Such demonization of e-cigarettes is inappropriate, and authors and journal editors share culpability.  Greater effort should be made to avoid bias in reporting of scientific data, particularly when public health is at stake.

Friday, May 17, 2013

Regulating, Taxing E-Cigarettes



As previously noted (here), e-cigarettes are winning over American smokers.  E-cigs’ vapor of nicotine, water and propylene glycol is vastly safer than smoke, and these products satisfy smokers’ behavioral cues.
 
Marketers have enjoyed a regulatory moratorium since federal judge Richard Leon blocked the FDA’s attempt to regulate e-cigs as drug-delivery devices in 2008 and 2009 (here).  His ruling was upheld on appeal (here).  As a result, on April 25, 2011, the FDA announced that e-cigs are tobacco products (here).

After some delay, the FDA recently indicated that it may issue its first set of so-called “deeming regulations” on alternative tobacco products this summer. There is considerable speculation as to what form those regulations might take.

Given that the agency has shown no interest in tobacco harm reduction, its regulatory scheme for e-cigs might mirror that for cigarettes and traditional smokeless tobacco products.  That could include onerous advertising and marketing restrictions that would cripple efforts to increase awareness and trial of e-cigs by smokers.

Because e-cigs are tobacco products, they will be saddled with heavy federal and especially state excise taxes.  Cigarette consumption is gradually declining, which means that state payments from the 1998 Master Settlement Agreement are in decline.  To counter that, some states have raised cigarette taxes dramatically, which ironically threatens legal sales and tax revenue and encourages black marketeers.

Tobacco prohibitionists, including medical associations, federal agencies and state health departments, don’t want smokers to switch to e-cigs; they will pressure legislators for high e-cig taxes that erase any economic advantage.  On the other hand, weak opposition to all taxes can be expected from loosely organized e-cig consumers, trade groups and individual marketers.  In that scenario, tobacco control and high taxes are likely to prevail.

Two states, Oklahoma and South Carolina, have considered a rational approach to e-cig excise taxes: a nickel per unit of nicotine solution, with the tax never to exceed one-tenth of the excise tax on a pack of cigarettes.  It’s not perfect – a 1:50 or 1:100 ratio would be more appropriate – but it’s a positive development for tobacco harm reduction, one I proposed ten years ago (here) and again in 2008 (here). 

As I wrote in 2003: “When it comes to taxes there are no easy answers.  But a rational tobacco tax strategy based on risk is as compelling as it is innovative, because it allows lawmakers to meet their fiscal responsibility while fulfilling their moral obligation to help smokers who are desperate to quit.”

Thursday, May 9, 2013

New York City: Prohibition Prison




New York Mayor Michael Bloomberg’s 2003 prison smoking ban produced a pervasive black market, where single cigarettes cost inmates $30, and a pack runs as high as $200, according to the New York Daily News (here).

That might sound shocking, but I predicted those unintended consequences nine years ago in a column for the Las Vegas Review-Journal, after the California State Assembly imposed a state-wide prison tobacco ban.

February 5, 2004
California, Cigarettes and Prisons: Ban Smoking, Not Tobacco
 
Brad Rodu
Special to the Las Vegas Review Journal

On January 26 the California Assembly passed a bill that would ban all tobacco products in state prisons (Assembly Bill No. 384).  According to sponsor Tim Leslie (R-Tahoe City), the bill “is a win, win, win for California.”  But the ban may be a loser for everyone else concerned, including prisoners, staff and the prison system. 

According to Leslie, about 80,000 California prisoners smoke.  At 1½ packs per day and $3 a pack, prison sales of cigarettes in California is worth $131 million.
  
One hundred million dollar markets just don’t disappear with the stroke of a legislative pen.  They transform, and often in ways that don’t please prison officials.

First, the California prison system will lose the revenue generated by sales of legal tobacco products.  But over-the-counter revenue lost is under-the-table revenue gained, as smuggling takes over and entrepreneurs compete for the lucrative tobacco market.  In Colorado prisons, where tobacco prohibition was instituted four years ago, an $11 can of Bugler loose tobacco generates $5,000 in hand-rolled cigarettes—a 45,000% markup.  In other words, the Colorado ban spawned an instant black market serviced by prisoners and their families, guards, teachers and supervisors.  Officials have conducted 154 investigations – at considerable additional cost -- and made dozens of arrests.  All because Colorado officials chose in effect to ban nicotine, the consumption of which is absolutely legal everywhere in the US except behind bars.
 
Absolutely legal.  And almost absolutely safe.  Nicotine is among the most powerful of addictive substances, but it is not the reason that smokers die.  In fact, nicotine itself is about as safe as caffeine, another widely consumed addictive drug.  It is the other 3,000 agents in tobacco smoke that are responsible for the diseases that kill smokers.  Smokers who switch permanently to other, safer forms of nicotine, including smokeless tobacco products, live longer and healthier lives and don’t pollute the air around them.
           
There is a very simple alternative to a complete ban on tobacco and nicotine: corrections officials should offer smokers alternatives in the form of smokeless tobacco.  Smokeless tobacco satisfies smokers and serves as an effective permanent substitute, because it rapidly delivers a dose of nicotine comparable to that from smoking.  For comparison, nicotine medications provide only about one-third to one-half the peak nicotine levels of tobacco products, which is unsatisfying for many smokers.  In addition, medicinal nicotine is expensive and designed to be used only temporarily.  All of these reasons are why nicotine replacement has a paltry 7% success rate among American smokers.

Smokeless tobacco use is vastly safer than smoking, which is entirely consistent with the stated health goal of Leslie’s bill.  Our research documents that smokeless use imposes only about 2% of the risk of smoking.  The only consequential adverse health effect from long-term smokeless tobacco use is oral cancer, but even this risk is much lower than that associated with smoking.  In fact, the average reduction in life expectancy from life-long smokeless tobacco use is only 15 days, while the average smoker loses almost 8 years.  For further context, the risk of death from long-term use of smokeless tobacco (12 deaths in every 100,000 users per year) is about the same as that from automobile use (15 deaths in every 100,000 users per year).

Newer smokeless tobacco products deliver the nicotine kick smokers crave and they can be used almost invisibly.  Spitting, once the stigma of smokeless tobacco use, is nonexistent with these products.  New products are neatly packaged as wafers or small pellets of tobacco.  Some modern products are the size of breath mints and completely dissolve during use, leaving no tobacco residue.
    
Data from Sweden show that smokeless tobacco can easily substitute for smoking.  For 50 years men in Sweden consistently have had the lowest smoking rate and the highest smokeless tobacco rate in Europe.  The result:  Rates of lung cancer – the sentinel disease of smoking – among Swedish men have been the lowest in Europe for 50 years.  World Health organization statistics reveal that Swedish men have the lowest rates of lung cancer among 20 European countries.  In the US smokeless tobacco is already working for many Americans. Statistics from the Centers for Disease Control and Prevention (CDC) show that 1.5 to 2 million former smokers have chosen this option on their own.

In summary, when prison systems provide smokeless tobacco as a substitute to inmates who smoke, they accomplish several goals.  First, they promote the health of smokers by offering a cigarette substitute that is 98% safer for users (because smokers who switch to smokeless tobacco reduce their risk for all smoking-related illnesses, including mouth cancer).  Second they ensure the health of nonsmoking inmates and staff (because passive smoke is eliminated).  Third, they restore the prison tobacco market to its rightful balance, in which revenue from tobacco sales is removed from the black market and returned to the correctional facility.  In other words, corrections officials can meet both health and fiscal goals by providing an environment that is smoke-free, not necessarily nicotine and tobacco-free.

Unfortunately local, state and federal officials have blindly embraced tobacco prohibition.  Mayor Bloomberg’s policies have made New York City a tobacco prison, with cigarette prices, at $12-15 a pack, the highest in the nation.  Now he wants to prohibit cigarette sales to anyone under 21 years of age (here), which will force more of today’s legal consumers to the black market.

Half of the cigarettes sold in New York State are illegal, shifting a quarter billion dollars of government revenue to criminals  (article here). 

Prohibitionists love to claim the moral high ground, but they are bootleggers’ best friends.

Thursday, May 2, 2013

Snus and Moist Snuff May Be Protective Against Dental Cavities



One of the longstanding federal warnings on smokeless tobacco is: “This product can cause gum disease and tooth loss.”  This warning has no scientific basis.

I previously discussed a study from Sweden concluding that snus use was not associated with gum disease (here).  A 2012 study by the same research group concluded that “snus use does not increase the risk of dental caries [cavities].”

The latter study was based on 1,500 residents of Jönköping, Sweden, who underwent detailed dental health exams in 1983, 1993 and 2003. Lead author Anders Hugoson and colleagues employed teams of dentists who observed the number of teeth, saliva factors, oral hygiene and cavities.  A key indicator of cavities is the number of tooth surfaces that are decayed or already filled with silver or other material (abbreviated DFS).  A lower DFS means healthier teeth.

The study’s snus users in 1983 had an average 20 DFS, a statistically significant half of the 41 DFS in smokers and nonusers of tobacco.  In 1993, snus users had 22 DFS, compared with 37 in smokers and 36 in nonusers, also significant.  By 2003, the margin was narrower and not significant, but the 19 DFS among snus users was still lower than among nonusers (28) and smokers (29).

The results of this research were similar to an American study published in 1999 (abstract here).  It showed that while American chewing tobacco, which is coated with a sugar solution, is associated with cavities, users of moist snuff, with no added sugar, had lower cavity scores than nonusers of tobacco. 

Both of the above studies, however, were less than forthright in their portrayal of smokeless tobacco. It is the norm in epidemiologic research for risks among exposed groups to be compared with risks among a referent, nonexposed group.  In the Swedish studies, the protective effect of snus was masked by making snus users the “referent group” for some of the statistical analyses.  The American study was similarly flawed, as chewing tobacco users were the referent group, thus masking the protective effect of moist snuff. 

The authors of the American research, Drs. Scott Tomar and Deborah Winn, are outspoken tobacco opponents.  I have previously discussed Dr. Winn’s oral cancer misinformation campaign here, here  and here.

Why might snus and moist snuff be protective for cavities?  Neither product has any added sugar, and both probably stimulate saliva production, which is generally protective against cavities.  In addition, smokeless products tend to have an alkaline pH, which Dr. Hugoson writes “may favour the remineralization of the tooth surfaces and the inhibition of the [cavity-forming] acid [bacteria].”    

 Unbiased scientific research and reporting is the best prescription for healthy teeth and healthy lives.