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Prepared Witness Testimony The House Committee on Energy and Commerce
Can Tobacco Cure Smoking? - A Review of Tobacco Harm Reduction.
Subcommittee on Commerce, Trade, and Consumer Protection
Dr. Scott L. Tomar DMD, DrP
Testimony of Scott L. Tomar, DMD, DrPH US House of Representatives, Committee on Energy and Commerce Hearing: Can Tobacco Cure Smoking? - A Review of Tobacco Harm Reduction Washington, DC June 3, 2003 1. Smokeless tobacco causes cancer and is addictive. To promote it as a "safer" alternative to smoking while safe sources of nicotine (patch and gum) are available is a mistake. Oral snuff is a finely cut, processed tobacco that the user typically places between the lip and gum. Nicotine is released from the tobacco and absorbed by the membranes of the mouth. In 1986, the US Surgeon General concluded that use of this product causes oral cancer, gum disease, and nicotine addiction. More recent research suggests that snuff use increased the risk of cardiovascular disease, including heart attack. Swedish research shows that male snuff users have twice the rate of cardiovascular death as non-users. Smokers should be encouraged to use proven, safe sources of nicotine to quit smoking not be encouraged to use snuff. There is no evidence that smokers who switch to oral snuff use have a lower risk of disease or death; they are still exposed to high levels of carcinogens. 2. USSTC has a long history of marketing oral snuff to young males with no history of tobacco use including promotion of low nicotine "starter" products. Allowing them to make "safety" claims may increase nicotine addiction among youth. Use of oral snuff has risen dramatically among young men. From 1970 to 1991, the prevalence of snuff use among men aged 18 and older rose from 1.5% to 3.3%; among men 18-24 years old, it increased more than eightfold from 0.7% to 6.2%, making this age group the heaviest users of the product among those surveyed. In the 1980s, USSTC operated a college marketing program on over 200 campuses. The company continues to routinely sponsor fraternity and college events today. In 1998, U.S. Smokeless Tobacco Company (USSTC) signed the Smokeless Tobacco Master Settlement Agreement (STMSA) settling lawsuits against USSTC and agreed not to directly or indirectly target youth in their advertising and promotion. USSTC continued to heavily advertise in youth magazines after signing the STMSA and USSTC annual advertising expenditure rose from $5.4 million pre-STMSA to $6.1 post. It was only after the Attorney General threatened legal action did the company drop ads in youth magazines. When Massachusetts banned smokeless tobacco advertising in 1999 near schools and playgrounds, USSTC and other tobacco companies successfully sued the state. A 1989 National Collegiate Athletic Association (NCAA) survey of college athletes found a 40% increase (from 20% to 28%) in smokeless tobacco use from 1985 to 1989. Among NCAA baseball players, an alarming 57% were users. There is new evidence that suggests that these increases are no accident, but the result of a sophisticated marketing campaign that developed, advertised, and promoted use of oral snuff starter products with lower levels of free (un-ionized) nicotine as part of a graduation strategy that intended new users to move up to brands higher in nicotine as tolerance developed. The high nicotine brands are highly addictive and high in cancer-causing nitrosamines. Public health groups aggressively worked to educate young people on the dangers of oral snuff. In 2001, 14.8% of male high school students reported current use of smokeless tobacco, down from 20.4% in 1993. According to the University of Michigan, that decline was due to an increase in their knowledge about the dangers of smokeless tobacco. Allowing USSTC to make claims that these products are "safer" than cigarettes could reverse this and result in an increase by youth.
3. USSTC has failed to protect consumers by failing to inform by not lowering known cancer-causing agents in its products or informing consumers about their toxic and addictive properties. Oral snuff contains dangerously high levels of cancer casing agents called tobacco specific nitrosamines (TSNAs). Unlike the major cigarette companies, who now admit that their products cause cancer and are addictive, USSTC doesn't acknowledge or inform their consumers that conventional oral snuff causes cancer or is addictive. In addition, USSTC refuses to report product content, nicotine dosing, or the levels of TSNAs by brand. In 2000, the Massachusetts Department of Public Health contracted with the American Health Foundation to determine how new and existing technologies affect the levels of tobacco specific nitrosamines in six brands of oral snuff. The Department obtained brands of snuff sold in the state as well as one brand, Ettan, sold in Sweden. The America Health Foundation research found that the Swedish Match brand and its U.S. subsidiary brand had total TSNA levels between 2.8 ug/g (Ettan) and 7.5 ug/g (TimberWolf). These levels were far lower than that found for the standard brands available in the state. UST, Swisher and Conwood brands ranged from16.6 ug/g to 127.9 ug/g. The same study examined the effect of product aging over two, four and six months. Product aging involves placing the tobacco product on a shelf at room temperature and retesting the TSNA levels at the specified time periods. The study found that certain U.S. brands had large increases in TSNA levels. Copenhagen increased 137% over the six-month time period and Skoal increased 20%. Silver Creek increased 9% over a four month time period. No significant changes were observed in the levels of Swedish Match or its subsidiary brands. The study shows that the levels in the brands manufactured under new technologies were significantly lower than levels of TSNAs in those brands that were produced under the standard manufacturing processes. Also, brands that employed the new processes show no increase in TSNAs when aged. The study demonstrates that it is technologically feasible to produce oral snuff products for adults that are significantly lower in TSNAs than many of those currently on the market. USSTC has the manufacturing technology to reduce the level of nitrosamines to the same level as those found in Swedish products in all of their brands, yet they have not done so. According to the 2000 Surgeon General's Report, "if a new technology exists that can significantly reduce levels of known carcinogens in a tobacco product, then that technology should be used." Before manufacturers make claims that oral snuff is a "safer" alternative to cigarette smoking, TSNA levels should be lowered to the maximum extent possible for all products. Biomarkers should also be developed to determine if a reduction in TSNAs actually reduces cancer risk and the research and any claim of reduced harm approved by an independent health regulatory agency. USSTC has refused to disclose the levels of TSNAs in their brands, warn consumers about possible TSNA formation and aging or voluntarily reveal the amount of free nicotine (additive potential) in their product to consumers. I met with USSTC attorneys and representatives several years ago, when I was an epidemiologist with the Office on Smoking and Health, and asked the company to provide to this information to the American people; they not only refused to provide it, they denied that they are able to manipulate the nicotine dosing properties of their snuff products. It has been firmly documented in the scientific literature that USSTC can, and does, control the nicotine dosing properties of its products, and has used that ability to promote addiction among young people. When Massachusetts passed a law requiring the disclosure by brand of additives that effect toxicity and addiction, USSTC and the other tobacco companies successfully sued Massachusetts.
4. Promotion of oral snuff as a "safer" alternative to smoking may have unintended public health consequences. I recently published two studies on this topic. The first looked at a smoking initiation among U.S. males aged 12-17 and found that young males who were not smokers at baseline but smokeless tobacco users were three times as likely to be smokers four years later (23.9% vs. 7.6%) as young males who never used smokeless tobacco. In contrast only a 2.4% of current smokers and 1.5% of never smokers became smokeless tobacco users by follow-up. The second study looked at adult male tobacco users and found that U.S. men were 2.5 times more likely to be former snuff users who now smoked than to be former smokers who currently used snuff. One in five males who were daily snuff users also smoked. This combined use of tobacco products may undermine the impact that smoke-free policies have on quitting smoking. This research suggests that smokeless tobacco may be a gateway for adolescent smoking and males in the United States are far more likely to switch from snuff to cigarette smoking than vice versa. In USSTC's current advertising for its low TSNA snuff brand, Revel, the brand is marketed as a complement to smoking, not as a complete substitute or as a way to quit smoking. There is no information included in the ads or packaging on the dangers of smoking including lung cancer, no advice on how to quit smoking or information about smoking cessation programs. Rather the product is marketed for use in settings when smoking is barred and in doing so result in undermining the impact of clean indoor air laws on smokers' decision to quit. USSTC use similar marketing messages for its SKOAL snuff products. These products can actually delay or prevent smoking cessation. 5. There is no evidence that oral snuff use is effective in helping smokers to quit, either in the United States or Sweden. Not a single randomized controlled trial has been reported that shows that oral snuff is effective in helping smokers to quit. Such evidence is required before the manufacturers of any other drug can make health claims about their products. In contrast, USSTC has presented no credible evidence that their products are effective smoking cessation devices, yet their proposed marketing strategy clearly implies that smokers can switch to their snuff products. USSTC's proposed marketing strategy amounts to a widespread, unregulated experiment on human populations. Such an experiment may have very serious negative side-effects, including promotion of tobacco initiation by young people and reduced rates of smoking cessation among adult smokers. Even in Sweden, where claims have been made that oral snuff use is responsible for its declining smoking rates, there is no evidence that snuff played a major role. In fact, careful examination of the data from Sweden reveals the following: (1) per capita consumption of cigarettes remained constant in Sweden during the 1970s while snuff use was rapidly increasing, suggesting that the growth in snuff use was not the result of substitution of cigarettes for snuff; (2) nearly all of the growth in oral snuff use in Sweden since the 1970s has been among males who started using these products when they were 16-24 years old, the group that also had the lowest smoking cessation rates in Sweden, and not among adult smokers trying to quit; (3) the prevalence of daily smoking has been declining among men and women in Sweden since 1980, although less than 2% of Swedish women use snuff and the prevalence of daily snuff use among men has remained relatively constant; (4) several large studies that followed cohorts of Swedish adults over time found that smokers who also used snuff were no more likely than smokers who did not use snuff to quit smoking; (5) a very small proportion of Swedish smokers who quit did so by switching to snuff; and (6) tobacco control measures implemented in Sweden, including bans on all tobacco advertising in periodicals and electronic media, prohibition of free products and industry sampling practices, dissemination of health information about smoking, increased taxation on cigarettes, and widespread clean indoor air policies are probably responsible for most of the decline in smoking in Sweden. 6. Major health bodies have carefully looked at this issue and recommended that smokeless tobacco not be promoted as reduced harm products until more research is done and the research and claims are approved by a health, regulatory agency. The Institute of Medicine (IOM) and the World Health Organization have both reviewed this issue and have concluded that smokeless tobacco should not be promoted as a "safer" alternative to smoking. IOM concluded that more research is needed and according to IOM, research and claims on "reduced" harm products, including smokeless tobacco, should be reviewed and approved by an independent health regulatory agency before they are marketed. Sweden has lowered smoking rates but this is due to the Swedish comprehensive tobacco control program and not the availability of snuff. Massachusetts and California have reduced male smoking far below that of Sweden (14% MA, CA daily smoking vs. 18% Sweden). This has been done without promoting snuff as a safe substitute to smoking. In fact, we have been able to reduce the use of cigarettes and snuff among young people and adults in the United States in the past decade. Safe forms of nicotine are available including nicotine gum and patches that have been approved as effective smoking cessation medications by the Food and Drug Administration. These should be promoted as ways to quit smoking, not smokeless tobacco. 7. Research on the advertising for other "reduced risk" tobacco products shows that advertising may be deceptive and misleading. The Massachusetts Tobacco Control Program (MTCP) has conducted two studies on advertising claims for other "safer" tobacco products. The first was R.J.R's Eclipse cigarette, which made a claim that there was no cigarette like Eclipse based on a comparison of smoke carcinogens between Eclipse and a "typical" ultralight cigarette, Merit Ultra Light. RJR claimed that the level of carcinogens was 80% lower than Merit. MTCP commissioned research comparing Eclipse to two other ultra light cigarettes, Now and Carlton, and found that Eclipse actually had higher levels of certain carcinogens. Eclipse had 734% more acetaldehyde than Now and 475% more acreolein. Also, as RJR redesigned this product from its 1988 predecessor, Premier, to present, levels of NNK increased by 1200% from 2.4 ng/g to 32 ng/g and NNN increased 160%. Based on this research, MTCP has concluded that the claim by RJR that "There is No Cigarette Like Eclipse" is deceptive since MTCP found two existing brands, Now and Carlton, that had similar levels of smoke carcinogens.
A second study MTCP commissioned was a Mall Intercept Survey of 600 smokers who reviewed ads for Omni and ADVANCE cigarette brands compared to ads for regular and light cigarettes. The Institute of Medicine has called these products PREPS, potential reduced exposure products. Study results are based on a convenience sample of 600 smokers 18-65 years old. Respondents were asked to examine selected advertisements for Regular cigarettes, Light cigarettes, and the new tobacco products (ADVANCE, Eclipse, and Omni) and answer questions regarding their perceptions of the products advertised and the messages conveyed by the specific advertisements. In side-by-side comparisons, smokers indicated that they thought PREP products posed fewer tobacco-related health risks, lower levels of carcinogens, and lower tar levels. Specifically: · Smokers perceived PREP tobacco products as having lower health risks than Light or Regular cigarettes. · Smokers perceived PREP tobacco products as having a lower level of things that might cause cancer than Light or Regular cigarettes. · Smokers perceived PREP tobacco products as having a lower level of tar than Regular cigarettes, and a similar level to Lights. · Perceptions of PREP tobacco product's health risks relative to Light cigarettes were generally consistent across subgroups of the study population. · Men, people with lower educational attainment, and white non-Hispanic individuals were more likely than others to perceive that PREP tobacco products pose lower health risks than do Regular cigarettes. Prior to participating in this study, only a few smokers had seen advertisements for or had smoked PREP tobacco products. For the vast majority, the primary source of information for assessing PREP tobacco products' properties, including their health and safety, were the advertisements viewed during the study. Their opinions regarding the advertisements included the following: · Most smokers interpreted the PREP tobacco product advertisements as conveying positive messages about health and safety. · Many smokers interpreted the PREP advertisements as saying that these products would be helpful in quitting smoking. · Most smokers believed that claims made in cigarette advertisements must be approved by a government agency.
In conclusion, smokeless tobacco causes oral cancer, and if promoted as a "safer" alternative to smoking may actually increase cigarette use. Florida, Massachusetts, and California have reduced smoking rates without promoting smokeless tobacco and safe forms of nicotine such as gum and patch already exist. These should be promoted as ways to quit smoking as part of comprehensive tobacco control campaigns.
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