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.

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.