FDA Cigar Study Part II: Heart & Lung Disease Nearly Zero for 1-2 Cigars Per Day

As noted in my last blog post (here), data presented in a recent FDA review of cigar health risks (here) showed that smoking up to two cigars per day, while not completely safe, is neither associated with significantly increased risks for death from all causes, nor smoking-related cancers.       

Now we examine the FDA data regarding cigar-related circulatory and lung diseases. Here are the overall results:

Table 1. Relative Risks for Mortality From Circulatory Diseases and Emphysema Among Men Who Smoke Cigars
Disease	Study, Year	Relative Risk (95% CI)
Coronary heart disease	Kahn, 1966	1.04 (0.96 – 1.13)
	Carstensen, 1987	1.16 (0.84 – 1.57)
	Ben-Schlomo, 1994	0.45 (0.17 – 1.22)
	Shanks, 1998	1.05 (1.00 – 1.11)
	Jacobs, 1999	1.30 (1.05 – 1.62) 1
	Jacobs, 1999	0.93 (0.72 – 1.21) 2
Stroke	Kahn, 1966	1.08 (0.91 – 1.28)
	Shanks, 1998	0.96 (0.87 – 1.06)
Aortic Aneurysm	Kahn, 1966	2.06 (1.32 – 3.07)
	Carstensen, 1987	5.10 (1.33 – 13.19)
	Shanks, 1998	1.76 (1.29 – 2.35)
Atherosclerosis	Kahn, 1966	0.97 (0.69 – 1.33)
Emphysema	Kahn, 1966	0.79 (0.25 – 1.86)
	Carstensen, 1987	1.30 (0.00 – 7.45)
	Lange, 1992	3.70 (1.10 – 12.00)
	Shanks, 1998	1.42 (0.96 – 2.03)

¹Age 30-74 years

²Age 75+ years

    

Compared with never smokers, cigar smokers in most studies had no elevated risks for coronary heart disease, which is one of the most common smoking-related causes of death in the U.S.; the single exception was a subgroup of men, age 30-74 years, in the Jacobs study.  Cigar smokers also did not have increased risks for two other frequent causes of death, stroke and atherosclerosis (hardening of the arteries).

Aortic aneurysm – a bulge in the heart’s main artery – is the only disease risk that is consistently elevated in cigar smokers.  It is a serious disorder but a distinctly uncommon cause of death; the mortality rate due to aortic aneurysm among those 45 and older dropped precipitously from 16 deaths per 100,000 in 2000 to 7.4 in 2014.

For men who smoke only one or two cigars a day, the health risks are even lower.

Table 2. Relative Risks for Mortality From Circulatory Diseases and Emphysema Among Men Who Smoke 1 or 2 Cigars Per Day
Disease	Shanks, 1998	Other Studies
Coronary heart disease	0.98 (0.91 – 1.07)	1.00 (0.90 – 1.10)1
		1.18 (0.76 – 1.82)2
Stroke	1.01 (0.88 – 1.17)
Aortic Aneurysm	1.82 (1.11 – 2.81)
Emphysema	1.39 (0.74 – 2.38)

¹Kahn 1966, fewer than 5 cigars per day.

²Jacobs 1999, 1 cigar per day.

No elevated risks for coronary heart disease, stroke or emphysema among men smoking 1-2 cigars per day.  The only disease that was significantly elevated was aortic aneurysm.

The Take-Home Message for Cigar Smokers

Puffing and/or inhaling the smoke of burning tobacco is not without risks.

The FDA, which now regulates tobacco products, seems inclined to treat cigars the same as cigarettes.  FDA staff wrote in their cigar study that “…cigar smoking carries many of the same health risks as cigarette smoking…We have observed that some risks associated with cigar smoking can be as high or higher than those associated with cigarette smoking, especially at the highest doses and levels of inhalation for cigar smoking.”

The problem with such a sweeping indictment is that it ignores scientific evidence and misleads cigar smokers who could substantially benefit from truthful harm reduction guidance.

Like any risky behavior, the degree of risk is proportional to dose and duration of exposure.  In other words, risk is based on frequency of cigar smoking and the degree to which smoke is puffed and/or inhaled.

ZERO U.S. & Canada Cancer Deaths from Smokeless Tobacco, British Researchers Report

A study published in BMC Medicine (here) estimates that the number of cancer deaths due to smokeless tobacco (ST) use in the U.S. and Canada is ZERO. 

The researchers, mainly from the UK, had bad news for ST users in Southeast Asia, where products have high levels of contaminants and are mixed with other toxic ingredients like betel.   Deaths in that region contributed the lion’s share of the worldwide toll of 267,000 annual deaths from cancer and heart disease among ST users. 

The researchers developed risk estimates based on epidemiologic studies from each region.  As I have discussed many times, the risk of cancer among Swedish and U.S. ST users is so small that it is not statistically significant.  Attributing no U.S. cancer deaths to smokeless tobacco use, the UK researchers confirmed this.

They also estimated deaths from ischemic heart disease among ST users.  I have noted that several studies document the risk of heart attack among smokeless users in the U.S. and Sweden as “next to nil” (here, here, here and here).  Ignoring these published risk estimates, the UK researchers declared that “no good country-specific risk estimates were available.”  They assigned a risk value of 1.6 based on an international heart attack study that included ST use data from countries like Bangladesh, India, Pakistan, Sri Lanka, Nigeria and Cameroon, but not the U.S. or Canada.  Due to this, the UK claim of 11,000 heart attack deaths in the U.S. and Canada from ST use is a gross overestimate.

The U.S. and Canadian public should ignore scaremongering about ST deaths, as the real threat lies with adulterated products from Southeast Asia.  For Western ST users, there is much to celebrate in this report.

Colorado State Smoking Ban: No Impact on Heart Attacks

As early as 2004, various medical journals published articles claiming that small-community smoking bans resulted in nearly immediate reductions in heart disease.  For example, the high-profile BMJ reported that hospital admissions for acute myocardial infarction (AMI) declined 40%, from 40 to 24, in Helena, Montana, after implementation of a smoke-free ordinance (here).  Circulation, the journal of the American Heart Association, reported that AMI admissions dropped 27% “within months” in Pueblo, Colorado (here). Similar reports came from Bowling Green, Ohio (here), Monroe County, Indiana (here) and beyond. 

The striking implication was: Eliminating second-hand smoke saves lives by reducing heart disease.

There were two problems with these claims.  First, the declines, based on small numbers of observations, were actually consistent with random variation (here).  Second, none of the reports accounted for the long-term downward trend in heart disease in the U.S.; they credited no-smoking intervention with the lower number of AMIs at a time when rates were declining nationwide.

In 2011, I documented that state-wide smoking bans in California, Utah, Delaware, South Dakota, New York and Florida had little or no immediate measurable effect on AMI deaths. The study, published in the Journal of Community Health (here), eliminated the “tiny-number” problem and factored in the national downward trend in AMI deaths.

I discussed these findings in my blog (here), but the work was largely ignored, until now.

Recently, researchers from three Colorado institutions reported AMI rates before and after a statewide smoking ban there; their work appears in the American Journal of Medicine (here).  (Thanks to Chris Snowdon, who also blogged about it here).

Paul Basel and colleagues found that “No significant reduction in [AMI] rates was observed” after the Colorado ban was implemented.  They also referred to our study:

“[The Rodu et al.] study compared the decline in [AMI] mortality in 6 states with smoke-free ordinances, with the average decline among 44 states unaffected by smoke-free policy.  No state with a smoke-free ordinance had a significantly lower observed [AMI] mortality compared with that expected by the nationwide secular decrease in states without the ordinance.  This emerging evidence highlights the importance of accounting for secular trends in [AMI] incidence before definitive attribution to smoke-free ordinances can be made.” 

It is comforting to see unfounded second-hand smoke claims corrected, particularly in the pages of a prestigious journal.

Pipe Smoking and Health

Health risks associated with cigar smoking are lower than those for cigarette smoking, reflecting a lower exposure to smoke toxicants (see my earlier post here).  The same holds true for pipe smoking, as a 2004 American Cancer Society study documented (abstract here).

Dr. S. Jane Henley and colleagues examined data from the Cancer Society’s Second Cancer Prevention Survey, which enrolled participants in 1982.  They compared deaths among exclusive men pipe smokers with those among never tobacco users over the next 18 years.  They also considered the number of pipes smoked each day, duration of smoking, and how much smokers inhaled.  The results are expressed as hazard ratios (HRs, similar to relative risks); a confidence interval spanning 1.0 means the risk elevation was not statistically significant.

The table shows that pipe smokers had small to moderate elevations for several smoking-related diseases, with the risk for laryngeal cancer remarkably high.

The Health Risks of Pipe Smoking
Disease	Hazard Ratio (95% Confidence Interval)
Cancer
Oral cavity and pharynx	3.9 (2.2 – 7.1)
Esophagus	2.4 (1.5 – 4.0)
Stomach	1.2 (0.7 – 1.9)
Colon Rectum	1.4 (1.2 – 1.7)
Pancreas	1.6 (1.2 – 2.1)
Larynx	13.1 (5.2 – 33)
Lung	5.0 (4.2 – 6.0)
Bladder	1.5 (0.9 – 2.4)
Kidney	0.9 (0.8 – 1.6)
Heart Disease	1.3 (1.2 – 1.4)
Stroke	1.3 (1.1 – 1.5)
Emphysema	3.0 (2.2 – 4.1)

The Cancer Society’s analysis of pipe smoking was thorough (in stark contrast to its consideration of smokeless tobacco, discussed here), producing a wealth of insights.  For example, the overall HR for lung cancer among pipe smokers was 5.0, but there was a distinct gradient related to the number of pipes smoked per day.  The HR was 2.0 with one to three pipes, but it increased to 7.7 for 11+ pipes per day.  There was a similar trend with longer duration of smoking, and inhalation played a major role.  The lung cancer HR was 2.9 for pipe smokers who didn’t inhale, but 11.1 for those reporting moderate or deep inhalation. 

Other diseases showed similar trends with dose, duration and inhalation, although some  results weren’t statistically significant.

Dr. Henley also illustrated that alcohol is a powerful risk factor for cancers of the oral cavity, pharynx, larynx and esophagus.  Pipe smokers who consumed less than one alcoholic drink per day had no increased risk for these cancers.  Those consuming 1-3 drinks had an HR of 4.7 (CI = 1.8 – 11.9), while those consuming 4+ drinks had much higher risk (HR = 15, CI = 5.9 – 39).  Never smokers consuming 4+ drinks also had elevated risk for these cancers (HR = 2.3, CI = 1.2 – 4.3). 

“These risks,” according to the researchers, “were generally smaller than those associated with cigarette smoking and similar to or larger than those associated with cigar smoking.”  This confirms one of the tenets of tobacco harm reduction: it’s the smoke that kills, and the risk is proportionate to how much, how long and how deeply smoke is inhaled.