WHO FCTC May Kill Millions of Smokers

It is shocking to read that the Parties to the World Health Organization Framework Convention on Tobacco Control (WHO FCTC) want to prevent the use of two of the most effective methods for achieving smoking abstinence. (http://www.scoop.co.nz/stories/WO1011/S00426/tobacco-convention-agree-on-stronger-smoking-controls.htm)

Smoking prevalence rates have stagnated. The United States Centers for Disease Control and Prevention as stated: ““To further reduce disease and death from cigarette smoking, declines in cigarette smoking among adults must accelerate.” (CDC MMWR Vol. 59 / No. 35 http://www.cdc.gov/mmwr/PDF/wk/mm5935.pdf)

When used as directed to wean down and off nicotine, medicinal nicotine products have a success rate of 7% at 6 months, 5% at one year, and only 2% at 20 months. (Moore D, et al. Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis. BMJ 338:b1024 2009 http://www.bmj.com/content/338/bmj.b1024.full.pdf+html)

The main reason medicinal nicotine products are so ineffective is that they require sustained nicotine abstinence. As soon as treatment ends, relapse begins. Dr. Brad Rodu of the University of Louisville states, ““Given that the outcome measure for all smoking cessation trials in the U.S. is complete abstinence, it is no wonder that most cessation methods are deemed failures. For successful tobacco regulation, the FDA must break the public health community’s addiction to abstinence promotion.“ (http://rodutobaccotruth.blogspot.com/2010/10/noteworthy-news-from-norway-snus-is.html)

Let’s compare the success rate of medicinal nicotine to methods that do not require nicotine abstinence.

Dr. Karl Erik Lund compared quit rates, defined as the percentage of ever smokers who are now former smokers, among snus users and never users of snus in seven previously published Norwegian surveys. The results were published in Addiction magazine. (http://www.ncbi.nlm.nih.gov/pubmed/2088345)

Lund Survey No.	Quit Rate - Snus Users (%)	Quit Rate - Never Snus Users (%)
1	80	52
2	55	23
3	81	63
4	62	53
5	75	45
6	90	50
7	73	43

It is important to note that not all smokeless tobacco products are alike. Swedish snus is formulated to reduce cancer-causing nitrosamines. Studies show that the health risks associated with Swedish snus use are significantly lower than the health risks of continued smoking. An assessment by Gartner, et al published in Lancet found “There was little difference in health-adjusted life expectancy between smokers who quit all tobacco and smokers who switch to snus (difference of 0.1-0.3 years for men and 0.1-0.4 years for women). For net harm to occur, 14-25 ex-smokers would have to start using snus to offset the health gain from every smoker who switched to snus rather than continuing to smoke. Likewise, 14-25 people who have never smoked would need to start using snus to offset the health gain from every new tobacco user who used snus rather than smoking.” (http://www.ncbi.nlm.nih.gov/pubmed/17498798)

As for electronic cigarettes, most of the world-wide panic has been generated by a very misleading press conference held by the U.S. Food and Drug Administration regarding their testing of 18 electronic cigarette cartridges made by the two companies engaged in a lawsuit against the agency (a strong signal of bias).

The FDA failed to point out that the highest quantity of “carcinogens” detected in a cartridge is equal to the quantity in an FDA-approved nicotine patch (8 nanograms). The quantity of diethylene glycol detected was so miniscule that a 150 pound person would need to ingest the contents of 100,000 cartridges in a single day to be poisoned. So why all the panic? Electronic cigarettes are about as dangerous as FDA-approved nicotine products, which makes them several orders of magnitude safer than smoking.

Critics keep claiming that there is no proof that electronic cigarettes help people to stop smoking. If by “stop smoking” they mean “achieve total abstinence from nicotine” then the critics are correct. However, if what they mean by “stop smoking” is to stop inhaling smoke and to enjoy all the resulting health benefits, then the critics are wrong. Surveys of electronic cigarette users consistently show that a large majority of users are able to substitute the electronic cigarette for all of their smoked cigarettes.

Survey #	# Subjects	Quit Rate
Heavner K, et al. Electronic cigarettes (e-cigarettes) as potential tobacco harm reduction products: Results of an online survey of ecigarette users, Tobacco Harm Reduction Yearbook 2010.	303	79%
Etter JF. Electronic cigarettes: a survey of users. BMC Public Health 2010, 10:231.	81	63%
The Consumer Advocates for Smoke-Free Alternatives Association, online survey of e-cigarette users.	2217	80%

Here is a summary of the success rates for the three methods of achieving smoking abstinence:

Method	Success Rates
NRT	Best Case: 10-15% As directed: 2-7%
Swedish Snus	55-90%
Electronic Cigarettes	63-80%

If the WHO FCTC succeeds in pushing electronic cigarettes and smokeless products such as Swedish snus off the market, they will have succeeded in making a significant contribution to the death of millions of smokers who could have quit smoking by switching to a safer source of nicotine.

Reality Faces Off Against Unfounded Fears

Compare and contrast reality with fears about electronic cigarettes voiced by people who have never seen one, never talked to anyone who used one, and never bothered to read the available studies.

The Fears - As reported in the Annals of Internal Medicine, Volume 153, Number 9, p. 607-609 (“E-Cigarettes: A Rapidly Growing Internet Phenomenon”):

We contend that the e-cigarette boom presents important public health concerns on at least 3 fronts. First, e-cigarettes may pose a risk as starter products for nonusers of tobacco. Although candy-flavored tobacco products and e-cigarettes were recently banned by the FDA in efforts to hinder marketing toward children, the posturing of e-cigarettes as “green” and “healthy” could deceptively lure adolescents. E-cigarettes also may represent a way for adolescents and adults to skirt smoke-free indoor air laws.

The Reality - As reported in Chapter 19 of the Tobacco Harm Reduction Yearbook 2010 (“Electronic cigarettes (e-cigarettes) as potential tobacco harm reduction products: Results of an online survey of e-cigarette users”):

All respondents previously smoked and 91% had attempted to stop smoking before trying ecigarettes. About half (55%) were 31-50, while 32% were >50 years old. Most (79%) of the respondents had been using e-cigarettes for <6 months and reported using them as a complete (79%) or partial (17%) replacement for, rather than in addition to (4%), cigarettes. The majority of respondents reported that their general health (91%), smoker’s cough (97%), ability to exercise (84%), and sense of smell (80%) and taste (73%) were better since using e-cigarettes and none reported that these were worse. Although people whose e-cigarette use completely replaced smoking were more likely to experience improvements in health and smoking caused symptoms, most people who substituted e-cigarettes for even some of their cigarettes experienced improvements.

Similar results were seen in two other surveys of users. J.F. Etter’s “Electronic cigarettes: a survey of users,” published in BMC Public Health reported, “Our results suggest that most people who buy these products are current and former smokers who use ecigarettes to help quit smoking, just as they would use NRT.” The median age was 37, ranging from 19 to 65 years. An unpublished survey conducted by the Consumer Advocates for Smoke-Free Alternatives Association (casaa.org) found that 50.9% of the 2,217 responders were between ages 30 and 49 years and 27.4% were older than 50 years, and 99.6% had been smokers.

Thus, reality certainly does not match the fears that e-cigarettes will be “starter products” geared towards adolescents and children. It is interesting that critics of e-cigarettes accuse manufacturers of offering flavors as a means of attracting children, but do not accuse the makers of Nicorette gum of luring children to their products via White Ice Mint, Cinnamon Surge, and Fruit Chill flavors.

Lastly, reality faces off against fear #3. E-cigarettes are not burned. Therefore they produce no smoke. Expressing fears that people will use them to “skirt smoke-free indoor air laws” is as ridiculous as fearing that children will purchase root beer as a means of defying laws against sales of alcohol to minors. Root beer isn’t an alcoholic beverage, and vapor isn’t air-polluting smoke.

Authors Yamin, Bitton, and Bates end their Annals of Internal Medicine essay with this statement: "Although the safety and efficacy of e-cigarettes is uncertain, we believe that clearly counseling patients against e-cigarette use, as well as other tobacco use, is prudent." Presumably, the authors would prefer that smokers stick with the FDA-approved smoking-cessation products that have a success rate that ranges from 2% to 7% when used as directed.

It is estimated that there are now a million former smokers who achieved their smoking abstinence by switching to e-cigarettes. It isn't at all prudent to recommend that they stop using e-cigarettes and risk relapse, nor is it prudent to steer current smokers away from a product that has a success rate that ranges from 63% to 80% based on the three surveys mentioned above.

Biological Basis of the Need for Nicotine

Nicotine is neither a nutrient nor a naturally occurring substance in the body. However, nicotine mimics the effects of acetylcholine (ACh) throughout the body, and ACh is a naturally-occurring substance. Although brain disorders can be caused by injury or strokes, most of them are caused by imbalances in neurotransmitters.

And nicotine appears to provide a corrective action for some of these imbalances.

Nicotine is being studied for treating Attention Deficit Disorder, chronic pain disorders, depression, anxiety, and memory impairments. It also works to prevent some of the nastier side-effects of medications used to treat schizophrenia. Nicotine prevents the build-up of alpha synuclean protein deposits in the brain which has implications for the prevention of dementia and Parkinson's Disease.

Many of the diseases that we used to call “mental” or “behavioral” we now know have a basis in biochemistry. There is still a tendency, I think, for people to hold those who have a brain disorder responsible for healing themselves. The “crazy people” should be able to “control themselves” better, the reasoning goes.

How many kids with true hyperactivity disorders were beaten for their misbehavior? And look how long we blamed those with stomach ulcers for being “too uptight” and "refusing" to relax — when in reality the cause of their disorder was a bacterial infection!

So I’m asking you to open yourself to the possiblity that feeling ill in the absence of nicotine and experiencing symptom improvement in the presence of nicotine is not necessarily a moral failing. It just might have a biological basis. This would explain why some folks need nicotine and others do quite well without it.

FDA Can’t Handle the Truth

Recently the U.S. Food and Drug Administration (FDA) invited the public to submit suggestions to the Center for Tobacco Products for educational resources to be added to the training program for Tobacco Retailers. http://tobaccoideas.fda.gov/forums/76427-improving-fda-tobacco-retailer-communication-tools

I submitted the following suggestion on September 19, 2010.

Relative Risks

Provide printed information comparing risk of smoking-related diseases from cigarette smoke to reduced risk from switching to smokeless products.

After I submitted the suggestion, the following feedback was displayed: “Your suggestion is awaiting moderator approval.”

OK, it’s understandable that the FDA would want to make sure that off-topic or off-color suggestions are weeded out before displaying them to the rest of the word. Since my suggestion was submitted over the weekend, I waited until Monday to see my suggestion displayed so that others could vote upon it.

Returning to my specific suggestion at http://tobaccoideas.fda.gov/forums/76427-improving-fda-tobacco-retailer-communication-/suggestions/1070375-relative-risks I saw that the “Awaiting moderator approval” message was still displayed.

I noticed the following message on the page.

PLEASE NOTE: To review our comment policy, visit http://go.usa.gov/3jT. We will only post on-topic comments on communication tool suggestions for retailers.

I clicked the link to determine whether the suggestion I submitted met the FDA guidelines, which read as follows:

FDA Center for Tobacco Product’s Tobacco Ideas Web site allows and encourages public comments and votes. We expect that participants will treat each other with respect and abide by the Terms of Service. All comments posted to the Web site will be reviewed and approved by the administrator before posting. We will not allow comments that contain vulgar or profane language; personal attacks of any kind; or offensive terms that target specific ethnic, religious or racial groups. We will not allow comments that are clearly off topic, spam, or that promote services or endorsement of any financial, commercial or non-governmental agency. The appearance of comments and external links on this site does not constitute official endorsement on behalf of the U.S. Food and Drug Administration.

Was my suggestion “off topic”? I found the following description of the program for which the FDA was seeking suggestions. (http://www.fda.gov/TobaccoProducts/ResourcesforYou/BreakTheChain/default.htm )

Break the Chain is FDA's new campaign to educate retailers and raise awareness about tobacco product regulations designed to protect kids from the dangers of tobacco use and its negative health impacts.

Medical research shows that 98-99% of the negative health impacts of tobacco use are caused by inhaling tobacco smoke. Tobacco retailers probably don’t know this. Like the rest of the American public, they have been misled into believing that the health risks of smokeless tobacco products are equal to the health risks of smoking. One of the government-required warning messages on smokeless products, “This product is not a safe alternative to smoking,” is interpreted by 85% of the public as “This product is no safer than smoking.”

Allowing the public to believe “you might as well smoke” perpetuates the worst of the negative health impacts of tobacco use. What if, however, smokers were provided with truthful information about relative risks so that they could make informed decisions?

In Sweden, providing the public with truthful information about the reduced health risks of using low-nitrosamine “snus” (a type of moist snuff) has led to Sweden enjoying the lowest smoking rates of any country in Europe. One study surveyed 6752 adult Swedes on tobacco use. They found that those who used snus were significantly less likely to start smoking. Among male smokers who later began using snus, 88% ceased daily smoking completely. Women using snus were significantly more likely to be able to stop smoking than those using nicotine patches or gum. "The main lesson of this study is that significant sections of the public would select a less harmful high-nicotine smokeless product over cigarettes and use it long term in place of smoking."
Ramstrom (2006) Role of snus in initiation and cessation of tobacco smoking in Sweden. Tobacco Control 2006;15:210-214. http://tobaccocontrol.bmj.com/content/15/3/210.abstract

But what effect does switching to Swedish snus have on health? Researchers reviewed the literature to identify studies that provided quantitative risk estimates associated with Swedish snus and cigarette smoking in a single population.

“Seven studies were identified that addressed eight health outcomes. Although few in number, these seven studies do provide quantitative evidence that, for certain health outcomes, the health risks associated with snus are lower than those associated with smoking. Specifically, this is true for lung cancer (based on one study), for oral cancer (based on one study), for gastric cancer (based on one study), for cardiovascular disease (based on three of four studies), and for all-cause mortality (based on one study).”
Roth (2005) Health risks of smoking compared to Swedish snus. Inhalation Toxicology. 2005 Dec 1;17(13):741-8. http://www.ncbi.nlm.nih.gov/pubmed/16195209

More recently, products have been bought to market that provide the look and feel of smoking without exposing the user or bystanders to the dangerous products of combustion. Instead of focusing on the huge potential of electronic cigarettes to reduce smoking-related disease, the FDA has chosen instead to exaggerate the importance of miniscule, harmless quantities of nitrosamines and utilize propaganda techniques to mislead the public into believing the products present "acute health risks."

So how could providing truthful information on relative risks of tobacco products to retailers protect kids from negative health impacts of tobacco use? Wouldn’t it lead to increased use of tobacco, resulting in increased negative health impacts?

If retailers were provided with documentation that switching to smokeless products reduces health risks, and if retailers informed smokers of the truth, odds are good that some smokers--perhaps many smokers--would make the switch, as happened in Sweden. There would be fewer adult smokers providing a role-model of smoking as a grown-up activity. If kids did learn this well-guarded secret, they would be less likely to start with or to progress to the much more harmful activity of smoking.

Two full business days have passed, and my suggestion still has not been published. On second thought, what did I expect?

Given the latest slogan coming out of the tobacco control community, “There is no safe form of tobacco,” it is doubtful that the FDA will ever agree to provide truthful information to the public. Admitting that some forms of tobacco are less harmful than others would expose the big, fat dirty lies for what they are.

Millions of smokers whose lives could have been saved by switching to safer alternatives have died over the past two decades as a result of the government-led disinformation campaign. Withholding the truth and engaging in misdirection are forms of lying, make no mistake. These lies kill people.

A Case of Legalized Extortion

I started to write this article in August, right after California Attorney General Edmund G. Brown Jr. announced a settlement with Sottera, the corporation that markets the NJOY electronic smoking alternatives. http://ag.ca.gov/newsalerts/release.php?id=1965 Unfortunately, I was sidetracked by more pressing issues, and I let the matter drop.

Recently, however, it became clear to me that this issue needs to be addressed when I read a forum entry that cited the settlement as proof that the company has been engaged in wrongdoing. The writer argued:

“Why would Sottera/NJOY settle/agree not to sell to minors and to discontinue advertising smoking cessation claims/health claims with the CA AG office (and pay $85,000 in fines) if they had not previously been caught doing so?”

I pointed out that a lawsuit constitutes an accusation, not legal proof, and that the most logical explanation for signing a settlement was that Sottera’s attorneys provided an estimate of what taking the case through the California court system would cost. The total was probably much higher than the $85,000 extorted by Brown. Were this the only legal battle Sottera faced, it might be worth while to go the distance. However, Sottera is engaged in a lengthy and costly legal battle with the U.S. Food and Drug Administration (FDA) in the Federal court system.

And it is this legal battle at the Federal level that is at the core of Brown’s suit. Late in 2008, the FDA began seizing incoming shipments of electronic cigarettes as unapproved new drugs. Smoking Everywhere filed suit against the FDA, asking for an injunction against product seizures. Sottera, which had also had large shipments seized, joined the suit as an Intervenor Plaintiff.

Apparently piqued at the audacity of the two companies for suing the FDA, the director of Action on Smoking and Health (ASH) decided to take matters into his own hands. He sent a letter to all 50 Attorneys General of each state, asking them to take legal action against Smoking Everywhere and NJOY

California’s Brown and Oregon Attorney General John Kroger apparently saw a PR opportunity and filed suit against both companies. The filings repeated the unfounded accusations from the ASH letter. Neither Attorney General bothered to conduct any type of investigation regarding the truthfulness of the accusations.

Had either AG even bothered to visit the NJOY web site, they would have seen that visitors are asked to verify that they are of legal smoking age before proceeding. The accusation that the products are targeted to non-smoking minors is further belied by text on the package of replacement cartridges:

"NJOY products are intended for use by those of legal smoking age and older, not by nonsmokers or children, nursing or pregnant women, or persons with or at risk of heart disease, high blood pressure, diabetes, or taking medicine for depression or asthma."

Nevertheless, the California Consent Judgment requires Sottera to promise not to market its products to minors. It should be noted that the Consent Judgment stipulates, “The Parties enter into this Consent Judgment without a trial. It does not constitute evidence of an admission by the Defendant regarding any issue of law or fact alleged in the Complaint.” http://ag.ca.gov/cms_attachments/press/pdfs/n1965_sottera_consent_judgment.pdf

Bottom Line: Signing the Consent Agreement does not constitute an admission of guilt on the part of Sottera/NJOY.

Most of the other items stipulated in the Injunctive Relief section of the Consent Judgment involve Sottera promising to begin performing actions that it has been doing ever since the business started, or promising to stop doing things it never did in the first place.

“Defendant shall have and maintain a system for quality control of Covered Products to ensure that they are manufactured to appropriate specifications,” reads the Consent Judgment. “TESTED IN THE USA. GLOBALLY DISTRIBUTED. MADE IN CHINA,” reads the NJOY package text.

“Defendant shall not advertise Covered Products as smoking-cessation devices unless or until they have been approved by the Federal Food and Drug Administration as such under its authority to regulate drugs, devices, or tobacco products,” reads the Consent Judgment. “NJOY products are not a smoking cessation product and have not been tested as such,” reads the NJOY package text.

“Defendant shall not sell Covered Products containing vitamins or other substances intended to portray that using Covered Products will improve one’s health, without competent, reliable scientific evidence to support the implied health claim,” reads the Consent Judgment. This requirement is not too difficult for NJOY to implement, in view of the fact that the company has never sold cartridges containing anything other than propylene glycol, water, and flavoring, with optional nicotine.

Some of the provisions of the Settlement Agreement are downright absurd. The requirement, “Defendant shall not make claims about Covered Products having no tar without competent reliable scientific evidence to prove the claims,” illustrates ignorance of basic science. Numerous laboratories have tested the content of electronic cigarette vapor, but none has ever bothered to test for the presence of tar—for very good reason. Tar is created by the process of combustion. Nothing is burned in an electronic cigarette.

The most absurd requirement of all is “Defendant shall not make claims about Covered Products containing no tobacco without competent reliable scientific evidence to prove the claims.” It does not require a rocket scientist to look inside an electronic cigarette cartridge to verify that there is no tobacco present.

So what do you call it when the AG extracts a "fine" of $85,000 from a company that has committed no wrongdoing? Some would call that extortion. It adds insult to injury for the AG’s press release to malign the company by implying that wrongdoing has been committed in the past.

Central Michigan University: Just Keep Smoking, Kids

A Central Michigan University (CMU) official recommends that students stick with smoking real cigarettes. Shaun Holtgreive, associate director of Residence Life at CMU, announced that electronic cigarettes are banned for indoor use anywhere on campus. Holtgreive claims to have studied e-cigarettes and says, “research has shown they give off noxious chemicals in the vapor expelled when smoked.”

If the pronoun “they” refers to e-cigarettes, Mr. Holtgreive has a credibility problem. No such research exists.

Smoke contains tar, carbon monoxide, particles of ash, and thousands of chemicals created by the process of combustion. Many of these are present in exhaled tobacco smoke. The vapor from an e-cigarette does not contain any of these constituents because nothing is burned.

Research has shown that, in an e-cigarette cartridge containing nicotine extracted from tobacco, the liquid has trace amounts of tobacco specific nitrosamines. The FDA pointed this out when they announced the results of their testing. However, the agency neglected to mention that the same “carcinogens” are present in FDA-approved nicotine products, in roughly equivalent amounts. [1,2] A trace amount of a tobacco humectant, diethylene glycol was found in the liquid from one cartridge. The FDA did not find any harmful chemicals in the vapor. Numerous other laboratories have found no harmful chemicals in the vapor. [3]

Surveys of e-cigarette consumers have shown that a sizeable majority—up to 79%--of e-cigarette users become former smokers. [4] Holtgreive wants these former smokers to go the designated smoking area and be exposed to second-hand smoke when they use the device that is keeping them smoke-free. He said these regulations are to keep a safe environment for students and those around them.

These same surveys show that over 90% of users are reporting health improvements. “Positive effects reported with ecigarettes included their usefulness to quit smoking, and the benefits of abstinence from smoking (less coughing, improved breathing, better physical fitness),” stated researcher Jean-François Etter. [5]

In the August 2010 issue of Cancer Epidemiology, Biomarkers & Prevention, researchers from Virginia Commonwealth University reported on a clinical trial comparing health effects of subjects’ own brand of cigarettes to two brands of electronic cigarettes and to sham smoking. Own brand and both brands of electronic cigarette significantly decreased tobacco abstinence symptom ratings. Like sham smoking, the two brands of electronic cigarettes had no significant impact on plasma nicotine levels, heart rate, or exhaled carbon monoxide. [6]

There have been numerous reports of people who had no intention of quitting smoking spontaneously losing their urges to smoke tobacco soon after they began using an e-cigarette. Allowing indoor use of e-cigarettes provides an incentive for continuing smokers to give the products a try. Treating e-cigarette users as though they were exhaling smoke sends a message: Just keep smoking, kids.

Sources:
[1] Westenberger BJ. Evaluation of e-cigarettes. U.S. Food and Drug Administration.
http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

[2] Laugesen M. Safety Report on the Ruyan® e-cigarette Cartridge and Inhaled Aerosol. Health New Zealand. (See “Comment 1” on page 7.) http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf

[3] The Consumer Advocates for Smoke-Free Alternatives Association, Resources, Lab Reports. http://www.casaa.org/resources/lab.asp

[4] Heavner K, Dunworth J, Bergen P, Nissen C, Phillips CV. Electronic cigarettes (e-cigarettes) as potential tobacco harm reduction products: Results of an online survey of e-cigarette users. Tobacco Harm Reduction Yearbook 2010. http://tobaccoharmreduction.org/wpapers/011v1.pdf

[5] Etter J. Electronic cigarettes: a survey of users. BMC Public Health 2010, 10:231. http://www.biomedcentral.com/1471-2458/10/231

[6] Vansickel AR, Cobb CO, Weaver MF, Eissenberg TE. A clinical laboratory model for evaluating the acute effects of electronic "cigarettes": nicotine delivery profile and cardiovascular and subjective effects. Cancer Epidemiol Biomarkers Prev. 2010 Aug;19(8):1945-53. Epub 2010 Jul 20.
http://www.casaa.org/files/VCU%202010%20E-cigarettes%20Acute%20Effects.pdf

What If We Told the Truth About Snus?

In a recently published study in the British Medical Journal Tobacco Control, Adrienne B Mejia, Pamela M Ling, and Stanton A Glantz state, “Promoting smokeless tobacco as a safer alternative to cigarettes is unlikely to result in substantial health benefits at a population level.” http://tobaccocontrol.bmj.com/content/19/4/297.abstract

The researchers used a Monte Carlo simulation to estimate the health effects of five different patterns of increased use of smokeless tobacco. Here we see the age-old principle of GIGO at work: Garbage In, Garbage Out.

Dr. Joel L Nitzkin, Chair, Tobacco Control Task Force of the American Association of Public Health Physicians questioned both the underlying assumptions applied in creating the computer models and the scoring arbitrarily assigned for various health effects. http://tobaccocontrol.bmj.com/content/19/4/297.abstract/reply#tobaccocontrol_el_3470

One of the critical assumptions applied in the calculations was the rate at which smokers would be willing to substitute snus for Smoking. Dr. Nitzkin commented, “All of their data on switching rates in the United States is conditioned on the warning on smokeless tobacco products, in place in the USA since 1984, that this product is not a safe alternative to cigarettes. This purposely misleading warning has left over 80% of American smokers with the incorrect impression that smokeless tobacco products present the same risk of tobacco-related illness and death as cigarettes.”

How might those estimates change if we all told smokers (and their doctors) the truth?

What if the government changed the warning labels to read "THIS PRODUCT IS NOT A 100% SAFE ALTERNATIVE TO SMOKING"? See what a difference one tiny change can make? This would lead folks to ask, "Well if it's not 100% safe, how much safer is it?"

The way the message is worded now, 85% of the people who read it conclude it means that smokeless tobacco products cause just as much disease and premature deaths as smoking. [1] We know it isn't true. But smokers don't know that, now do they?

And then what if the American Cancer Society, American Heart Association, American Lung Association, American Medical Society, and the Centers for Disease Control and Prevention informed smokers that their excess risk of lung disease would be totally eliminated if they switched from smoking to smokeless? What if they provided comparisons between smoking and smokeless of the odds of developing various types cancers, having a heart attack or a stroke?

We know that users of smokeless tobacco products have a lower mortality rate from all these diseases than continuing smokers. [2,3] We know that for most diseases, the Swedish snus user's mortality risks are reduced to the level of those who gave up all use of tobacco. [4] We know all that. But the smokers do not know that.

Most smokers do not read medical journals. They rely on the popular press and information provided by respected organizations that claim to have public health as a mission.

Curiously, most physicians are just as misinformed as their smoking patients. What if the doctors were to learn that their patients could reduce their risk of developing a smoking-related disease by 90 to 99% if they switch completely to a smokeless form of tobacco? Might not more smokers give snus a try if their own doctor told them it was safer than smoking?

What if the FDA required the tobacco companies to develop and conduct advertising campaigns aimed at convincing smokers to switch to smokeless products?

What if we did all these things? What effect would that have on the number of U.S. smokers who switch and consequently on the smoking-related morbidity and mortality rates? Factor in truth-telling and run those Monte Carlo simulations again.

References:

[1] Phillips, C.V. et al. You might as well smoke; the misleading and harmful public message about smokeless tobacco. BMC Public Health 2005, 5:31doi:10.1186/1471-2458-5-31.

[2] Accortt, N.A., et al. Chronic Disease Mortality in a Cohort of Smokeless Tobacco Users. American Journal of Epidemiology 2002; 156:730-737

[3] Roth, H.D. et al. Health Risks of Smoking Compared to Swedish Snus. Inhalation Toxicology, 17:741-748, 2005.

[4] Gartner C.E, et al., Assessment of Swedish snus for tobacco harm reduction: an epidemiological modeling study. Lancet. 2007 Jun 16;369(9578):2010-4