Minnesota Researchers to Smokeless Users: You’re Better Off Smoking!

In mid August the American Chemical Society, “the world’s largest scientific society,” held its national meeting in Washington, DC. The ACS has an impressive media machine, and on August 16 it was mobilized to promote a presentation entitled “Analysis of 21 polycyclic aromatic hydrocarbons in smokeless tobacco by gas chromatography-mass spectrometry,” by Irina Stepanov, a research associate at the University of Minnesota Masonic Cancer Center. The ACS media blitz included a press conference with Stepanov, which you can watch here.

Stepanov made some utterly incredible claims during her presentation, which were reported in an article published on the website of U.S. News & World Report under the headline “Chewing Tobacco No Safer Than Smoking”:

(1) “Tobacco users who think it's safer to dip snuff or chew tobacco than smoke are dead wrong, researchers say.”

(2) “A study has found that taking one pinch of smokeless tobacco delivers the same amount of polycyclic aromatic hydrocarbons (PAHs) as smoking five cigarettes.”

Let’s be perfectly clear: Irina Stepanov was asserting not only that smokeless tobacco is not safer than smoking, but that it is five times more dangerous than smoking!

Readers of this blog are familiar with the epidemiologic evidence linking smokeless tobacco use and cancer: almost a big fat zero. Numerous research studies have established that the cancer risks from using smokeless tobacco are so low that they are barely measurable.

Irina Stepanov made her claims about smokeless tobacco at a very public national meeting, and the American Chemical Society was an enthusiastic partner in promoting her research to the media. Surprisingly, after launching this unsubstantiated attack on smokeless tobacco, both Stepanov and the Chemical Society have refused to share her presentation with this researcher.

On August 19, I emailed Stepanov requesting a copy of her presentation. Her response on August 22 was bizarre: “We are in process of publishing a full paper on this study. So, the abstract is the only material that is available for sharing.”

That excuse for withholding her data is unprofessional. Researchers routinely provide copies of their public conference presentations to others in academia, regardless of the pendency of publication of fuller texts.

Refusal to share a conference presentation may violate the spirit, if not the letter, of the National Institutes of Health grants policy on data sharing. NIH funds Stepanov’s research group, the University of Minnesota and the Masonic Cancer Center, which also promoted Stepanov’s Chemical Society presentation. The NIH position is crystal clear: “It is NIH policy that the results and accomplishments of the activities that it funds should be made available to the public. PIs and grantee organizations are expected to make the results and accomplishments of their activities available to the research community and to the public at large.”

This episode is simply the latest in a series of attacks on smokeless tobacco by Minnesota anti-tobacco extremists. Almost the same approach and rhetoric were used in these 2007 articles in the New York Times and Fox News.

The main objective of this blog is to “examine and comment on the scientific foundation for tobacco policies and fallacies.” But that examination and commentary is contingent upon the scientific information being made available. In this case, Irina Stepanov, assisted by the American Chemical Society, has made a mockery of the long-standing tradition of open communication of scientific information.

Heart Attack and Stroke Risks from Smokeless Tobacco Use: Next to Nil

The International Agency for Research on Cancer (IARC) is a component of the World Health Organization with a mission “to identify the causes of cancer so that preventive measures may be adopted and the burden of disease and associated suffering reduced.” It is therefore not surprising that IARC staff have played a prominent role in exaggerating the cancer risks of smokeless tobacco use. The IARC anti- smokeless tobacco campaign has been led by Paolo Boffetta.

Boffetta, a cancer epidemiologist, departed from his field of expertise to complete (with co-author Kurt Straif) a review of the risks for heart attack and stroke among smokeless tobacco users in the U.S. and Sweden. The analysis has just been published by the British Medical Journal.

Boffetta reported that the summary relative risk (RR) for heart attack among smokeless tobacco users was 0.99, with a 95% confidence interval (CI) of 0.89 to 1.10 (For a discussion on how to interpret RRs and CIs, see my recent post). For stroke, Boffetta reported a minimal increase in risk (RR = 1.19) that was not statistically significant (CI = 0.97 – 1.47). Thus, the main finding in this study is that smokeless tobacco users have no excess risk of heart attack or stroke.

Given the importance of that conclusion, why did the researchers (in their BMJ abstract) and subsequent media coverage ignore it, focusing instead on fatal heart attack/stroke, one of two subgroups? It is because smokeless tobacco users had very small elevations in risk for the fatal events. For fatal heart attack the RR among smokeless users was 1.13 (CI = 1.06 – 1.21), and the RR for fatal stroke was 1.40 (CI = 1.28 – 1.54). Boffetta was unable to demonstrate that the excess risks were related to how much or how long smokeless tobacco had been consumed, two important characteristics that would have strengthened the validity of the findings.

There is a serious omission in this study. Boffetta divided all heart attacks and strokes into two subgroups, fatal and non-fatal. Boffetta found that smokeless users had no significant risk for all heart attacks and strokes but had elevated risks for fatal cases. It logically follows that smokeless users probably had LOWER risks for NON-FATAL heart attacks and strokes. But Boffetta provided no information about these subgroups, and the reason is obvious: it wouldn’t add to the health hysteria.

Here is the take-home message for smokeless tobacco users: You do not have elevated risks for heart attack and stroke. Although your risk for heart attack and stroke is the same as that of non-users of tobacco, there is a slight increased chance that, if one occurs, it could be fatal. This may be due to the effects of nicotine on the circulatory system, or it could be due to some other undiscovered factor that is associated with smokeless use. As Boffetta acknowledged, “the magnitude of the excess risk is small.”

In the article’s introduction, Boffetta wrote that smokeless tobacco “products have been proposed as an alternative to cigarettes and other smoking products under the claim of a smaller, or negligible, risk to health.” This study adds to the scientific evidence that, compared with cigarettes, the risks from smokeless tobacco are indeed vastly “smaller, or negligible.”

Tobacco Harm Reduction Gets the Nod in Norway

Norway occupies an interesting position in the European political arena, and in European tobacco issues. While it is located in the Scandinavian peninsula next to Sweden and has membership in the European Economic Area, Norway has twice rejected membership in the European Union. Thus, it has not been subject to the ridiculous EU policy in which vastly safer smokeless tobacco products are banned while cigarettes are freely available. In fact, information is now emerging from Norway that the increasing use of snus in the past 20 years has resulted in a substantial decline in smoking among Norwegian men, a virtual reproduction of the Swedish miracle that was documented by me and my colleagues in several published research articles.

The Norwegian tobacco harm reduction information was produced by Dr. Karl Erik Lund, a respected tobacco researcher with SIRUS, the Norwegian Institute for Alcohol and Drug Research. SIRUS is an independent institution, but it is also a government entity answerable to the Ministry of Health and Care Services. Lund has 20 years experience in tobacco research and more than 85 publications in the fields of tobacco epidemiology, evaluation and prevention.

Dr. Lund’s 2008 Presentation

In 2008, Dr. Lund gave a fascinating presentation on Norwegian tobacco use at the 51st conference of the International Council on Alcohol and Addictions. He reported that among Norwegian men age 16-35 years, the prevalence of smoking declined from 50% in 1985, to 30% in 2007, while the prevalence of snus use increased from 10% to 30%.

Lund reported that snus is very popular as a quit-smoking aid among Norwegian men. Among those who quit smoking in 2007, snus was used by 23%, while nicotine gum was used by only 9%; the nicotine patch, Zyban and a quit line were used by even fewer (6%, 3% and 3% respectively).

Lund also presented information about the outcome of the last quit attempt by Norwegian male smokers age 20-50 years in 2007. Of those who used snus, 74% “quit smoking altogether” or experienced a “dramatic reduction in smoking intensity.” It is important to point out that this success rate is essentially identical to the rate that we reported for American men who used smokeless tobacco to quit smoking. The percentages for those who used nicotine gum, patch and Zyban were 50%, 47% and 40% respectively.

We now have clear and compelling evidence that snus is a superior quit-smoking aid for men in Norway, in addition to those in Sweden and the United States.

Dr. Lund’s 2009 Report

Earlier this year Dr. Lund published (in Norwegian) a brilliant report on tobacco harm reduction entitled “A tobacco-free society or tobacco harm reduction? Which objective is best for the remaining smokers in Scandinavia?” Last week, the report was published in English, and it is available at this SIRUS website Following are some of the major findings.

Lund provided five compelling reasons why tobacco harm reduction is important:

(1) “…the effect of nicotine replacement products and the effect of interventions provided by doctors [are] very limited.”

(2) “A higher proportion of [remaining smokers have] social, mental and demographic characteristics associated with reduced ability to stop smoking.”

(3) “In Scandinavia, nearly all the political measures recommended by [the World Health Organization] for reducing smoking have already been implemented. There is probably little potential for further reduction by using publicly-regulated control of tobacco. Despite the fact that tobacco control measures are utilized to such a degree, the proportion of deaths due to smoking among adults is still very high.”

(4) “Intensifying the existing measures against smoking that have been effective up to now would probably give only a moderate return (diminishing marginal returns).”

(5) “Cigarette smoking is ideal for a harm reduction strategy, because the substance that causes addiction – nicotine – is not the cause of the health risk. People smoke because of nicotine, but die from tobacco smoke. Much less hazardous nicotine products are available.”

Lund argued that the slow implementation of tobacco harm reduction “is probably related to the widespread belief that it is possible to achieve a tobacco-free society.” He observed, “In order for harm reduction to be successful, consumers must receive correct information about the relative health risks of different types of nicotine products. Today, both smokers and general practitioners are misinformed.”

Lund also made a strong case that “Harm reduction policy must be made legitimate by the authorities. It is clearly a disadvantage and a hindrance for harm reduction if the snus industry [are] the most visible proponents of harm reduction.” He noted, “The health authorities in Norway and Sweden – where sale of snus is allowed – provide information about the health risks associated with the use of snus, but do not inform smokers about the health benefits that can be achieved by switching from cigarettes to snus. At worst, this can mean that nicotine-addicts remain smokers with no motive to try a harm-reducing alternative.”

Lund rejected the allegation that snus use is a gateway to smoking: “There is little empirical data from Scandinavia to support the hypothesis that snus increases the risk of starting to smoke. There is some empirical data to support the hypothesis that snus reduces the risk of starting to smoke.”

Lund concluded with a powerful summary:

Without encouragement to use harm-reducing nicotine products, a large proportion of remaining smokers will continue to smoke, and will thus have a 50 per cent chance of dying from a tobacco-related disease. With the status quo in tobacco/nicotine policy that is given legitimacy by the authorities – that is a policy without an active harm-reduction strategy – use of tobacco will maintain and strengthen future social inequalities in health status.

In Scandinavia up until now there has been little willingness to discuss harm reduction in the area of tobacco. The debate has been hampered by dogmatic statements of principle (particularly about snus) that suppress exchange of opinions and reflections about the ethical implications of harm reduction. Interest for – albeit limited – empirical research that can illuminate the theme has been moderate, taking into consideration the potential that harm reduction has for improving public health. Maybe this report can stimulate less biased debate?

In Scandinavia, the tobacco problem is not substantially less serious now than it was in the 1960s. At that time, doctors did not know the extent of the hazards of smoking, or that cigarettes would be the cause of so many deaths over the next 40 years. We now have knowledge about the extent of the hazards, nearly all conceivable preventive measures have been used, and we can predict future changes in smoking behaviour. In contrast to the doctors in the 1960s, we are now on the brink of a human catastrophe that we have been warned will occur if the reduction in smoking does not speed up. To ignore harm reduction as a future strategy in the area of tobacco can be erroneous in this situation. An uncompromising attitude to a tobacco-free society can deny many nicotine-dependent smokers the possibility to survive, which they could have had if the authorities had assumed a more pragmatic attitude to harm reduction.

The Norwegian Health Directorate Changes Its Views

It is important to point out that Lund’s report has already produced a dramatic change in the Norwegian Health Directorate's attitude toward snus as a quit-smoking aid. In the English translation, Lund added this epilogue:

About half a year before this report was published in English, an almost identical version was published in Norwegian. In Norway, the report received a lot of attention and stimulated a continuation of the debate on harm reduction, both in the media and in professional circles. The Norwegian Directorate of Health and representatives of the Norwegian Medical Association have some new points of view that can be interpreted as more positive to harm reduction ideology. For example, a director of division in the Norwegian Directorate of Health said to the newspaper Bergens Tidende under the headline "The Norwegian Directorate of Health is willing to consider snus":

"The Norwegian Directorate of Health says yes to general practitioners, dentists and other health care personnel being able to recommend health-damaging snus to inveterate smokers. Snus is clearly less damaging to health than smoking. If patients have tried other methods without success, we mean that health care personnel can recommend that they use snus instead," says Knut-Inge Klepp, director of division in the Norwegian Directorate of Health. He stresses that before such a recommendation can be made, other nicotine replacement products, and, if appropriate, medicinal nicotine products, must have been tried. Klepp also stresses that such a recommendation must be made directly by health care personnel to the person who needs advice. He is strongly against a general recommendation.

On the web site of the Norwegian Directorate of Health, a new attitude to use of snus as a harm-reducing product is confirmed:

"We know that a large proportion of people who smoke have contact with a dentist or a general practitioner," says Klepp. "It is important that health care personnel take up the topic of smoking, recommend quitting, and help people who wish to quit. In the first instance they should try established methods such as nicotine chewing gum, nicotine patches or medicinal nicotine products available on prescription. If patients have tried these methods without being successful, the Norwegian Directorate of Health means that health care personnel in individual cases can consider that the patient should try snus instead."

Tobacco harm reduction is happening in Norway, and Norwegian officials recognize that the lives of smokers are a higher priority than the demise of the tobacco industry.

Cancer Risks from Smokeless Tobacco Use: Next To Nil

Prohibitionist tirades against smokeless tobacco invariably focus on a presumed association with cancer. For example, these “fact sheets” from the American Cancer Society and the Campaign for Tobacco Free Kids are terribly misleading for all but very sophisticated readers. They boldly declare that smokeless tobacco causes cancer, but they fail to provide ANY evidence to support the claim. There’s a good reason for this deliberate misrepresentation: Scant evidence exists to link smokeless tobacco use with any cancer.

The Cancer Society and other anti-tobacco extremists cherry-pick various studies, taking a few isolated epidemiologic findings to justify their claims and ignoring the rest of the evidence that shows little or no risks from smokeless tobacco. This isn’t a scientific approach, and it should play no role in tobacco policy development. Unfortunately, this is exactly what has driven tobacco policy in the U.S.

Last week, United Kingdom epidemiologists Peter Lee and Jan Hamling published a comprehensive analysis of smokeless tobacco use and cancer in BMC Medicine, the flagship medical journal of the Biomed Central series, covering all aspects of medical science and clinical practice. Articles in this journal “need to be of outstanding quality, broad interest and special importance;” the Lee-Hamling study meets these criteria.

This study looked at ALL the epidemiologic evidence linking smokeless tobacco use and cancer. It compiled statistics from 89 studies, and it used a straightforward technique to separate the risk related to smokeless tobacco use from the risk related to smoking and alcohol consumption. That is especially important, since smokeless tobacco users may also have a history of smoking and heavy drinking, both of which are established risk factors for cancers of the oral cavity, throat and esophagus.

For each cancer, Lee and Hamling produced a summary of the relative risk (RR) of cancer among smokeless tobacco users, compared with non-users of tobacco. This is followed by a confidence interval (CI), which is the range within which the RR lies with 95% confidence. An RR of 1.0 indicates that the risk among smokeless users is the same as that among non-users, and any CI that spans 1.0 indicates that the RR is not statistically significant. An RR of 1.2 indicates an increase of 20%, while an RR of 2.0 indicates a doubling of the risk. It is also important to note that small RRs (those under 2) should not be seen as definitive evidence that ST caused those diseases. In fact, the National Cancer Institute advises: “Relative risks or odds ratios less than 2 are viewed with caution,” because they “are sometimes difficult to interpret.”

Oral Cancer

Lee and Hamling found 41 studies that reported risks for oral cancer. For all studies, the RR was 1.79 (CI = 1.36-2.36), indicating a modest elevation in risk. However, in the 19 studies that accounted for smoking, the RR was 1.36 (CI = 1.04-1.77); in the 10 studies that accounted for both smoking and alcohol, the RR was 1.07 (CI = 0.84-1.37). Thus, there is virtually no evidence that smokeless tobacco is an independent cause of oral cancer.

Lee and Hamling also found that, for studies published since 1990, the RR for smokeless use was 1.28 (CI = 0.94-1.76). This means that no significant oral cancer risk has been detected in users of modern smokeless tobacco products, which should provide reassurance for contemporary users.

Other Cancers

Lee and Hamling examined the evidence for many other cancers. Here is a summary of the risks among smokeless users (accounting for smoking), which can also be seen in Table 30 of their manuscript:

Esophagus: RR = 1.13 (CI = 0.95-1.36)
Stomach: RR = 1.03 (CI = 0.88-1.20)
Pancreas: RR = 1.07 (CI = 0.71-1.60)
All Digestive Tract: RR = 0.86 (CI = 0.59-1.25)
Larynx: RR = 1.34 (CI = 0.61-2.95)
Nasal: RR = 1.14 (CI = 0.73-1.77)
Lung: RR = 0.99 (CI = 0.71-1.37)
Prostate: RR = 1.29 (CI = 1.07-1.55)
Bladder: RR = 0.95 (CI = 0.71-1.29)
Kidney: RR = 1.09 (CI = 0.62-2.94)
All Cancers: RR = 0.98 (CI = 0.84-1.15)

The bottom line is that there is very little evidence that smokeless tobacco use is associated with any cancer. The only statistically significant finding in that list is for prostate cancer (RR = 1.29, CI = 1.07-1.55). But that RR is based on only four epidemiologic studies. As Lee and Hamling point out, the data for this finding “are inadequate for a clear conclusion…Prostate cancer is not considered smoking related, and more information on its relationship with smokeless tobacco is needed before any clear conclusion can be drawn.”

What If All Smokers Had Used Smokeless Instead?

Lee and Hamling also calculated how smokeless tobacco use might have changed cancer deaths among American men. In 2005, 142,205 men in the U.S. died from the 7 cancers associated with smoking. If no American men had ever smoked, there would have been only 37,468 cancer deaths, so 104,737 were directly attributable to smoking. Using the RRs above, Lee and Hamling calculated the number of cancer deaths that would have occurred if all smokers had instead used smokeless tobacco. The number attributable to smokeless tobacco would have been 1,102, which is only 1.1% of the deaths currently attributable to smoking.

Lee and Hamling then calculated another extraordinary statistic, a sort of worst-case scenario in which every man in the U.S. used smokeless tobacco. I assume that the investigators did this in order to counter anti-tobacco extremists who claim that releasing accurate information about the risks of smokeless tobacco would cause everyone to use it. In that case, according to Lee and Hamling, there would be 2,081 deaths attributed to smokeless use – a mere 2% of the deaths currently attributable to smoking.

It is difficult to exaggerate the importance of this study. The clear implication is that the deaths each year of 103,635 male smokers in the U.S. could be avoided if public health leaders shared the truth about safer smokeless tobacco, and if tobacco manufacturers were allowed and encouraged to urge smokers to switch.

As profound as the Lee/Hamling research is, it is astounding how little public and professional attention has been paid to it. Their study has to date been the subject of only a single media blog article in the Los Angeles Times on July 29.

The scourge of smoking-related deaths, preceded in most cases by years of debilitating and costly illness, should be viewed as an indictment of our public health and regulatory systems. Given the wealth of published research on the role of smokeless tobacco in tobacco harm reduction, aggressive smoker education on the subject should be a national and global public policy priority.

Smoking in the European Union: How Swede It Could Be

In 2002 and 2003, I worked with a group of scientists from Umeå University in Sweden on a series of research reports. We documented that use of smokeless tobacco (“snus” in Swedish) has played an impressive role in low smoking rates among Swedish men.

In 2005 we published another study, showing that smoking among Swedish women had started to decline as a result of increased snus use. Our findings were confirmed by studies published by other Swedes in 2005 and 2006 .

Unfortunately, the European Union (EU) Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) ignored this evidence when it published a report on smokeless tobacco in 2008 entitled “Health Effects of Smokeless Tobacco Products.” Although the report acknowledged that “…particularly in Swedish men, there is a clear trend over recent decades for smoking prevalence to decrease and for use of oral tobacco (snus) to increase,” it concluded that “…these trends could also be due to successful smoking reduction programs or other socio-cultural factors, and it is therefore not clear whether or by how much the availability of snus has influenced smoking prevalence.” The report also stated that “…it is not possible to extrapolate the trends in prevalence of smoking and use of oral tobacco if it were made available in an EU country where it is now unavailable.”

Along with Phil Cole, an epidemiologist at the University of Alabama at Birmingham, I decided to address the SCENIHR indecision on extrapolation. While it is not possible to predict to what extent the availability of snus would reduce smoking prevalence in EU countries other than Sweden, it is possible to estimate how smoking-attributable deaths would decline if these countries had the smoking prevalence of Sweden.

We looked at lung cancer mortality trends in EU countries, starting about 1950 and ending in 2002. Lung cancer is the sentinel disease of smoking, and a country’s lung cancer mortality rate (LCMR) provides a reasonable indication of the amount of smoking in that country. Our data came from the World Health Organization and the International Agency for Research on Cancer, and our study was published in the Scandinavian Journal of Public Health.

In 2002, there were 172,000 lung cancer deaths among men in the EU. If all EU countries had the LCMR of men in Sweden, there would have been 92,000 fewer lung cancer deaths. Using this data, we can calculate the number of deaths from smoking in EU countries and compare it to the number in Sweden. For men in the EU, 91% of all lung cancer deaths are attributed to smoking, and lung cancer accounts for 31% of all smoking-attributable deaths.

We estimate that there were 509,000 smoking attributable deaths among men in EU countries in 2002. If all EU countries had the smoking rates of Swedish men, there would have been only 237,000 deaths. In other words, 274,000 smoking-attributable EU deaths would have been avoided.

The following table lists the numbers for each EU country (no data was available for Belgium and Cyprus).

Country	Deaths From Smoking, 2002	At Swedish Rate	% Change At Swedish Rate
Austria	7,000	3,900	-44
Bulgaria	7,100	3,800	-46
Czech Republic	12,500	4,500	-64
Denmark	5,700	2,800	-52
Estonia	1,600	600	-66
Finland	4,100	2,600	-36
France	60,000	28,300	-53
Germany	83,700	43,700	-48
Greece	13,900	6,200	-56
Hungary	16,300	4,400	-73
Ireland	2,700	1,600	-43
Italy	75,300	34,200	-55
Latvia	2,600	900	-64
Lithuania	3,500	1,300	-63
Luxembourg	400	200	-53
Malta	400	200	-51
Netherlands	18,700	7,700	-59
Poland	48,500	14,400	-70
Portugal	7,000	5,100	-26
Romania	20,100	9,000	-56
Slovakia	4,900	1,900	-61
Slovenia	2,100	900	-58
Spain	46,100	21,100	-54
Sweden	5,200	5,200	---
United Kingdom	59,500	32,000	-46
All EU Countries	509,000	236,500	-54

The countries with the largest numbers of smoking-attributable deaths are Germany, Italy, France and the UK, which reflects both large populations and high smoking rates. If these countries had access to snus and men used it as frequently as those in Sweden, deaths would be reduced by half. The biggest proportional reductions would come in eastern EU countries like Poland (73%) and Hungary (70%), which have the highest smoking rates in the EU.

The large differences in LCMRs between Sweden and other EU countries occur only in men. For most of the last 50 years, the LCMR among Swedish women was the sixth highest in the EU. This context is important, because it has been suggested that vigorous anti-smoking campaigns since the 1970s are the major determinant of the low Swedish smoking rates. It is implausible that these campaigns were highly effective for Swedish men and almost completely ineffective for Swedish women. The striking difference in the relative EU ranking of Swedish men and women is firm evidence that snus use, not anti-smoking campaigns, has played the primary role in low LCMR rates among men in Sweden for over a half century.

World War II created millions of male smokers, resulting in very high LCMRs throughout Europe in the 1960s and 1970s. Men in Portugal, Spain and Italy, which had LCMRs similar to those in Sweden in the early 1950s, later experienced peak LCMRs that were four to six times higher, while the peak in Sweden represented only a three-fold increase. Even though snus consumption declined until 1969, its use was high enough to suppress smoking by Swedish men and to keep their LCMR among the lowest in the EU. Increasing snus consumption in the last two decades has been accompanied by further declines in smoking. If current trends hold, the LCMR for Swedish men may become lower than that for Swedish women by 2011.

Currently, snus is banned in all EU countries except Sweden. While it cannot be proven that the availability of snus would reduce smoking prevalence in other EU countries, our study shows that snus use has had a profound effect on smoking among Swedish men. It also reveals that 274,000 smoking-attributable deaths would be avoided if all men in all EU countries had the smoking prevalence of men in Sweden.

In 2008, an article in the prestigious medical journal Lancet argued that “…the absence of effective harm reduction options for smokers is perverse, unjust, and acts against the rights and best interests of smokers and the public health.” Our study clearly shows that, snus has the potential to help the EU avoid 274,000 smoking-related deaths every year.

It is time for the European Commission to make snus available to all European smokers.

The FDA Crusade Against E-Cigarettes

On July 22, 2009, the FDA released the results of laboratory tests of e-cigarettes, which were conducted by the Division of Pharmaceutical Analysis at the FDA’s Center for Drug Evaluation and Research. In a press release, the FDA said: “These tests indicate that these products contained detectable levels of known carcinogens…” The FDA report can be downloaded here.

For many years, I have investigated the cancer risks of cigarette smoking and smokeless tobacco use. As I wrote in a recent post, the FDA has never regulated nicotine effectively, and the agency had previously signaled its intention to ban e-cigarettes. So while the agency’s new analysis of e-cigarettes comes as no surprise, it does undermine the assumption that the FDA bases it oversight activities purely on scientific principles.

The FDA analyzed 18 cartridges from two e-cigarette manufacturers, Smoking Everywhere and Njoy (there are many other manufacturers). With respect to “carcinogens,” the agency looked at four tobacco-specific nitrosamines (TSNAs) with very long chemical names; I’ll abbreviate the agents here as NNN, NNK, NAT and NAB.

I have some experience with TSNAs, since I participated in a project with a scientist at the Swedish National Food Administration to measure the levels of these agents in smokeless tobacco products. Our research showed that TSNAs are present in most American tobacco products at extremely low levels, about 0.1 to 12 parts per million by weight. At this level of TSNAs, someone who puts 1 gram (about 1/28th of an ounce) of smokeless tobacco in his mouth is exposed to, at most, about 10 one-millionths of a gram of TSNAs. There is abundant scientific evidence that exposure at this minuscule level is not associated with ANY cancer in smokeless tobacco users.

The FDA analyzed 14 products from Smoking Everywhere, but the agency only reported the TSNA levels for 7 of those products. Why did the FDA test only half of the company’s products for carcinogens? And how did they choose those products? There are some clues in the report. First, the products that weren’t tested simply had blank boxes in the results chart. A footnote says, “Open boxes indicate the sample was not available for testing.” Another note in the methods section admitted that “…not all sample lots were available for analysis…as they were consumed in other testing.” In other words, the FDA didn’t purchase enough of the products to conduct the testing in a systematic and scientific manner. Maybe it’s a budget problem. On the Smoking Everywhere website cartridges are $9.99 each.

The FDA tested 3 out of 4 Njoy products for TSNAs.

What the FDA didn’t test is even more important than what the agency tested. The report noted that the “Nicotrol Inhaler, 10mg cartridge was used as a control for some test methods.” That inhaler is a pharmaceutical nicotine product that is regulated by the FDA, but the agency didn’t test the product for TSNAs. This is a critical omission, because in 2006 a published research study revealed that pharmaceutical nicotine products contain TSNAs. In fact, it’s been known for almost 20 years that nicotine medications contain TSNAs.

Why did the FDA analyze e-cigarettes for carcinogens, when there is no evidence the agency ever conducted carcinogen studies of products that they have regulated for over 20 years? Is it possible that the FDA approved medicines that contained TSNAs, but the agency is now disapproving e-cigarettes because they contain the same contaminants? To answer this important question, we have to know how high – or how low – the TSNA levels are in these products.

Unfortunately, the agency did not report TSNA levels. Instead, it reported that TSNAs were either “Detected” or “Not Detected,” which is entirely inadequate. For hundreds of years, one of the basic tenets of medicine has been “the dose makes the poison.” Mere detection of a contaminant is meaningless; the critical question is: At what concentration is it present?

So what does “Detected” mean in the FDA analysis? In other words, what was the lowest TSNA concentration that the test detected?

As I noted earlier, many tobacco products have TSNA levels in the single-digit parts per million range, a level at which there is no scientific evidence that TSNAs are harmful. According to the report, the FDA used an analytic method published in 2008. The report notes that “the published method is quite sensitive for the TSNAs…” and it goes on to explain that the level of detection is 40 parts per TRILLION.

The implications of this are astounding. Apparently, the FDA tested e-cigarette samples using a method that detects TSNAs at about 1 million times lower concentrations than are even possibly related to human health.

In summary, the FDA tested e-cigarettes for TSNAs using a questionable sampling regimen, and methods that were so sensitive that the results may have no possible significance to users. The agency failed to report specific levels of these contaminants, and it has failed to conduct similar testing of nicotine medicines that have been sold in the U.S. for over 20 years.

These are not the actions of an agency that is science-based and consumer-focused. These pseudo-scientific actions are clearly intended to form the justification for banning a category of products that are probably 99.9% safer than cigarettes. According to Dr. Murray Laugesen, a respected New Zealand researcher, “Simply banning e-cigarettes will simply consign thousands of e-smokers back to smoking tobacco and an early death.”

The FDA and anti-tobacco extremists who support it should be held accountable for their prohibitionist actions.

The FDA has a legitimate interest in two matters involving e-cigarettes: assuring that cartridges contain the advertised quantity of nicotine, and that they do not contain contaminants.

I welcome the FDA to correct any errors in this critique. I attempted but was unable to reach the scientist who conducted the analyses.

FDA: Futzing and Diddling Around with Nicotine

Last month Congress passed, and President Obama signed legislation giving the FDA regulatory authority over tobacco products. There is doubt about whether the FDA is the appropriate agency to oversee tobacco use among 45 million Americans. But one thing is certain: The agency has already botched the regulation of nicotine, the highly addictive but otherwise virtually harmless drug found in all tobacco products.

Nicotine replacement medications for smokers have been around for over 20 years. Almost 15 years ago, the agency moved some forms from prescription to over-the-counter status, which typically makes medicines more affordable and more available to consumers. Not this time.

Nicotine medications remain very expensive, they provide only a fraction of the nicotine available in cigarettes, and the FDA limits their use to only 10-12 weeks. In effect, the FDA is telling smokers: “Achieve abstinence (from tobacco and nicotine), or take your chances with cancer, heart attacks and emphysema.”

Doesn’t the FDA know that it’s the smoke that kills? Nicotine is not the cause of any smoking-related disease. It’s about as safe as caffeine, another addictive substance enjoyed by millions of consumers of coffee, tea and cola drinks.

The FDA has assured that nicotine medications are expensive and unsatisfying. First, they are exorbitantly expensive. Smokers struggle to afford $5 to $10 for a pack of cigarettes, so how can they fork out $30 to $50 for a box of nicotine gum or patches? Second, nicotine medications are extremely low-dose, so they don’t provide the nicotine spike that smokers get when they light up. Finally, smokers can only use nicotine medications for 10 to 12 weeks – a period that many find too short to enable them to quit smoking. 

 With a regulatory framework like this, no wonder nicotine medications are successful for only about 7% who try them. For what other medications does the FDA accept a 93% failure rate? It is outrageous that the agency and, for the most part, the public health community are complacent with this dismal statistic.

There are simple fixes for this mess, but the FDA has shown little interest. In 1995, I published an open letter in the Pittsburgh Tribune-Review to FDA commissioner David Kessler, urging him to make pharmaceutical nicotine products more available to smokers. The FDA did nothing over the next 12 years to make these medications more effective and more affordable.

In February 2008, New York State Health Commissioner Richard Daines filed a petition requesting minor revisions in package labeling and sale of nicotine that would greatly expand consumer awareness and availability. The petition was supported by numerous tobacco research and policy experts and organizations. The FDA responded by… Well, they didn’t respond at all. It is hard to imagine how the agency could do worse than to not approve these simple changes. And now Congress has given the FDA regulatory authority over all tobacco products.

The FDA signaled in April that it was about to make another mistake -- banning e-cigarettes, which are battery-powered devices delivering pure nicotine vaporized with propylene glycol (both of which are already approved for human consumption by the agency). The FDA rationale for the ban: “We don't want the public to perceive them as a safer alternative to cigarettes,” said FDA spokeswoman Rita Chappelle.

Apparently, the FDA does not want the public to know that e-cigarettes are safer, which is depressing, coming from the federal agency dedicated to “protecting and promoting your health.” Tobacco users who are looking to the FDA for science-based regulation cannot be impressed. Compared with combustible products, e-cigarettes are definitely minimal risk. For more information, visit End Smoking New Zealand, which has conducted laboratory tests on e-cigarettes.

The vast majority of e-cigarette users are former smokers. The FDA intends to ban a virtually risk-free nicotine delivery system, forcing users to resume cigarette smoking. This move is more bad news for those trying to quit, and it betrays President Obama’s inaugural pledge to “restore science to its rightful place.”
Cigarette smoking will continue to be a leading cause of death in this country until the public health community and government agencies drop their anti-nicotine agenda and start helping, rather than punishing, smokers who are desperate to quit their deadly habit without quitting nicotine altogether.