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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
Mr. Steven Burton
Introduction Thank you, Chairman Stearns. My name is Steve Burton and I am the Vice President of Smoking Control, Strategic Development and Switch for GlaxoSmithKline Consumer Healthcare (GSK). I have had responsibility for marketing over-the-counter nicotine replacement therapy products (Nicorette gum, NicoDerm CQ patch, and most recently the Commit lozenge) since they were switched from prescription status in 1996. On behalf of GSK, let me thank you and members of the Subcommittee for the opportunity to participate in this important hearing and to share GSK's views on the matter before Congress and the public health community at large. GSK applauds the subcommittee for holding this hearing titled "Can Tobacco Cure Smoking - A Review of Tobacco Harm Reduction." My testimony will concentrate on what can be done to help smokers who are concerned about their health and interested in reducing the risk of smoking. In particular, I want to offer what we have learned through our research with consumers to help illustrate what they expect novel tobacco products to provide and how they might be used in a real world setting. I will also comment on the adverse public health consequences that could arise when smokers have the new choice to use novel tobacco products instead of FDA approved medicines and other scientifically proven methods of quitting. We believe that an understanding of consumer beliefs and behavior can play a critical role in the design and effective implementation of public health programs and that will be our principal contribution today. Smoking as the Leading Cause of Preventable Death and Tobacco Control Policy Progress to Date You are familiar with the staggering statistics associated with the use of tobacco. 440,000 Americans die prematurely each year because of tobacco use (CDC 2002a). More than 6 million of our children alive today will die prematurely later in life because of their use of tobacco (CDC 2002b). The use of this deadly and addictive product constitutes the leading preventable cause of death and disease in the United States each year. While we need to accelerate our progress in reducing the harm of smoking, we should be proud of the fact that millions of smokers have been able to quit completely, youth initiation has been on the decline, and overall prevalence of smoking is slowly trending downward. These significant public health gains are the result of a combination of environmental factors and changes in public health policy led by our elected officials, our regulatory community and the public health field. Examples of these efforts include higher tobacco taxes, restrictions on smoking in the workplace and public places, greater availability of proven treatments, and successful state-based and national youth prevention programs. These and other factors have encouraged more smokers to make serious quit attempts and to be more successful in achieving a smoke free status. GSK has played a small but important part in the overall effort to help adult smokers become tobacco free, and our primary mission remains to reduce the mortality and morbidity associated with smoking by offering smokers proven methods of quitting completely - the ultimate way to reduce risk. New Challenges to Recent Progress in Helping Smokers Quit It is well established that overcoming an addiction to tobacco is one of the most daunting and enduring medical challenges an individual can face. In fact, it usually takes multiple attempts for most smokers to become abstinent, and each effort takes a high degree of motivation and personal courage to overcome the psychological and physiological effects of withdrawal from the highly addictive and often socially rewarding use of a cigarette. To overcome this powerful addiction, smokers need encouragement and support to promote quit attempts and to convert these attempts into positive health outcomes. This includes making effective use of available treatments. Smokers receive this encouragement in a number of ways - from their friends, their health care professional, and also from their government and other public institutions. The decision to quit is easily influenced by smokers' beliefs in their own ability to quit and by their understanding of the alternatives they have to mitigate the risks of smoking. Our research with smokers suggests that the unregulated availability of so-called reduced risk products could lead millions of smokers to delay or reconsider quitting. A perception that novel tobacco products have the endorsement of our public institutions would discourage smokers' commitment to quitting and introduce the confounding and potentially very deceptive notion that smokers can now reduce their risk or even "quit" by continuing to smoke with these novel tobacco products, a so-called "harm reduction" approach. While the health benefits of a harm reduction approach have yet to be proven and remain largely theoretical, the risks of unregulated access to novel tobacco products are clear and present dangers that could undo years of progress by Congress, the FDA and the public health community of which we are a part. As you no doubt have heard, the great fear held by many public health experts is that these new tobacco products may be nothing more than a scientifically sophisticated version of the "light" cigarette. The introduction of "light" and "ultra light" cigarettes is an object lesson in how policy decisions can unwittingly mislead the public and undermine cessation. Public health officials now believe, many decades too late to be of any help to the health-concerned smoker who switched to lights over the last thirty years, that lights appear to have been deliberately designed so as not to reduce tar and nicotine deliveries when smoked by human beings. As the National Cancer Institute recently stated, in the definitive study from the federal government on the deception linked with "lights," "Marketing this illusion of risk reduction would have been of concern even if the target for these brands had been confined to continuing smokers. Instead, these brands were targeted at those smokers who were thinking of quitting in an effort to intercept the smokers and keep them smoking cigarettes." (USDHHS, 2001, page 5) Due in large part to the deliberate design of "lights," there was no reduction in the death and disease burden from tobacco as a result of the marketing of "light" cigarettes. NCI concluded that "The absence of meaningful differences in smoke exposure when different brands of cigarettes are smoked and the resultant absence of meaningful differences in risk make the marketing of these cigarettes as lower-delivery and lower-risk products deceptive for the smoker. The reality that many smokers chose these products as an alternative to cessation-a change that would produce real reductions in disease risks-makes this deception an urgent public health issue." (USDHHS, 2001, page 1) Thirty years ago, well-intentioned public health officials encouraged health-concerned smokers who could not quit smoking to switch to "lights." At all costs, we must avoid repeating the mistakes with today's products that were made thirty years ago with "lights." Consumer Understanding of Risk of and Interest in Novel Tobacco Products At the outset, one critical fact must be recognized. Complete abstinence is the only method that reduces the future health risk of smoking to almost zero, and allows for an ex-smoker to achieve a long-term prognosis essentially equivalent to a never smoker after 10-15 years of abstinence (USDHHS, 1990). The emergence of novel tobacco products does not change this fact. Novel tobacco products have not been studied with the same rigor of smoking cessation medicines and methods. Nor have the studies that have been conducted on these products been submitted to FDA for evaluation. There is only one proven way to reduce the harm from tobacco, and that is to quit. On the other hand, consumers are all too willing to grasp at the belief that novel tobacco products are indeed safe and effective alternatives to smoking their current cigarettes. As an example, we fielded a large consumer survey that exposed the Eclipse concept (a novel cigarette design that is claimed to primarily heat rather than burn tobacco) to 1000 smokers and 499 ex-smokers. In the survey, after hearing a brief account of claims for Eclipse, almost all current smokers (91.4%) thought Eclipse was safer than Regular cigarettes. Moreover, almost a quarter (23.9%) considered Eclipse to be completely safe. On average, participants expected that Eclipse would reduce smoking risk by 62.1% compared to Regular cigarettes, with three quarters (75.9%) expecting that Eclipse would reduce health risks by at least 50%. Eclipse was also regarded as significantly safer than current Light or Ultra Light cigarettes. Compared to the 23.9% who regarded Eclipse as completely safe, only 9.4% and 11.3% regarded Lights and Ultra Lights, respectively, as completely safe. The fact that consumers perceive novel tobacco products to carry less health risk than smoking even light or ultra light cigarettes should be troubling to those who are concerned with the death and disease caused by tobacco products. We know that approximately 70% of smokers are interested in quitting (CDC, 2002c). GSK's mission is to reduce death and disease by inspiring more smokers to become tobacco, and ultimately, nicotine free. The scientific data behind our treatments, such as Nicorette gum, NicoDerm CQ patch, the Commit lozenge, and the prescription smoking cessation drug Zyban, has been evaluated and approved by the Food and Drug Administration. These products have been approved as being both safe and effective for use in trying to quit. With the help of our products and those of other treatment providers, millions of smokers in this country have successfully stopped smoking and eliminated all of the risk of continued tobacco use. Unintended Consequences of Novel Tobacco Products- Consumer Perspective From a public health perspective, we should be concerned about the new crop of tobacco products bearing unproven claims to reduce exposure and risk. The greatest danger is that these products may pose a significant threat to cessation efforts - regardless of whether a smoker would have used one of our products in a quit attempt or chosen another quit method. Smokers who see the claims for products like Eclipse may now think that a safer cigarette genuinely exists. This may make them less interested or inclined to try to quit smoking entirely. There is the added concern that ex-smokers may start smoking again, thinking that they can now safely consume tobacco products. Likewise, those who never smoked, particularly adolescents, may take up smoking for the first time, using one of these new products under the assumption that a safe cigarette exists. The consumer survey data commissioned by GSK on smoker and ex-smoker attitudes towards Eclipse, one of the new generations of tobacco products sold by R. J. Reynolds, confirms these concerns (Shiffman, Pillitteri, Burton, et al, unpublished manuscript). Reynolds makes explicit health claims about reductions in disease risks for Eclipse, including "less risk of cancer," and "a lower risk of chronic bronchitis, possibly even emphysema" (www.eclipse.rjrt.com, December 2002). The survey found that 57.4% of smokers said they were "somewhat likely" or "very likely" to purchase Eclipse within the next six months. Most importantly, after hearing about Eclipse, there was a net decrease of 19% in smokers who were contemplating quitting within 6 months. Furthermore, 15% of the young adults who had recently quit smoking were interested in buying Eclipse. In a second study focusing on a novel smokeless tobacco product among smokers interested in quitting, similarly high levels of purchase interest were reported. Around 41% of the sample were very or somewhat likely to want to use the novel smokeless product. Purchase intent (46%) was higher in consumers with an interest in using nicotine replacement therapy to quit, a surrogate for smokers more likely to actually commit to a serious quit attempt. When asked how they would use these smokeless products, 15% of the sample reported they would use the smokeless tobacco product as a substitute for cigarettes at times when they could not smoke, 29% as a way to reduce their smoking rate, and another 36% as a way to cut back on their smoking in preparation for quitting. These results suggest that Eclipse, and its new brethren of tobacco-based products that have not been proven to reduce the risk of smoking in any meaningful way, are a threat to cessation and risk converting ex-smokers back to their deadly addiction. Do these products genuinely reduce exposure and risk? We do not know because exposure and risk are determined by the overall pattern and years of use by smokers in real world conditions, not just by physical makeup of the product. Nor do we know how these products perform in the laboratory. But here are a few observations that should be of profound concern to the public health community of which you are a part. Eclipse advertising declares that exposure to carbon monoxide may be higher than traditional cigarettes. Eclipse has been shown to contain filaments of glass particles not found in traditional cigarettes that would be inhaled deeply into the lungs (IOM 2001). The new Quest cigarette offers a program claiming to reduce levels of nicotine consumption while keeping the level of cancer-causing tar unchanged - and the tar levels are higher than the majority of low tar brands consumed today. Many experts would argue that, as was the case with "light" cigarettes, smokers of Quest would consume a greater number of the reduced nicotine cigarettes in order to avoid withdrawal and maintain the reinforcing effects of their nicotine addiction. These smokers could end up consuming more tar with the reduced nicotine cigarette than their traditional brand of cigarette. Scientific Perspective - The Risk/Benefit Equation for Novel Tobacco Products I expect the scientific community and tobacco control experts to provide their view on the potential risks and benefits of expanded use of novel tobacco products. They believe the tobacco industry's motivation is to perpetuate the use of tobacco-based products by introducing a new generation of tobacco products. By offering promises of reduced exposure to toxins in tobacco smoke, and even making claims to reduce the risk of cancer and other diseases, these products raise profound and troubling public health policy questions for our partners in the tobacco control community. We should consider carefully the recent findings published in the American Journal of Epidemiology, that reductions in cigarette use, as measured by daily smoking rates, had no impact on health risks from smoking among a large population of heavy smokers (Godtfredsen et al, 2002). Smokers who attempt to reduce the harm of smoking by cutting down on the number of cigarettes they smoke compensate in the same way that smokers of so-called light cigarettes compensated by smoking each cigarette more deeply. Smokers who attempt to reduce their smoking rates without the support of pharmacotherapy experienced the same degree of harm as smokers who did not reduce their smoking rates. The novel tobacco products take various forms. Some burn tobacco or employ novel technologies to burn or heat tobacco. Others are tobacco-based but do not burn. The combusting products include Omni and Advance, and promise to reduce or eliminate exposure to a subset of toxins in tobacco smoke. The novel products include Eclipse and Accord, and claim to reduce toxin levels or secondhand smoke. The non-combusting (i.e. smokeless) products include Ariva, Revel, and Exalt, promise tobacco satisfaction in situations (e.g. at work or on a plane) where smoking is not possible or permitted. Whether they combust or not, all of these products are aimed squarely at the health-concerned smoker. They have entered the marketplace in the absence of any independent scientific evaluation of their claims, and without any governmental scrutiny of the products or their claims. Equally troubling are the claims for the smokeless products, like the Ariva tobacco lozenge. In isolation, one could argue that a tobacco-based product that does not burn tobacco leaf has a lower risk profile than one that does. But this could be a short-sighted view to take given the historical behavior of the smokeless tobacco industry operating outside of a credible regulated environment. Reviews of past marketing practices report that this industry deliberately targeted young males, particularly athletes, in the 1970s and revived lagging sales by promoting use of smokeless among teenage boys who had not previously used tobacco. Further, these same reports note that this industry specifically designed and promoted products with varying levels of nicotine delivery, perceived strength and a range of flavors (including "candy-like" flavors) so as to facilitate early use by adolescents and their progression to more addicting, higher nicotine products (FDA Proposed and Final Rule, 1995 and 1996; Bonnie and Lynch, 1994). Furthermore, the health benefits of products like Ariva presumably result in part from the assumption that Ariva would be used to completely replace all cigarette use and thus overall exposure to toxins would decrease. It is equally plausible that smokeless tobacco products would be used in addition to a smoker's typical level of cigarette consumption, and this is precisely the type of real world consumer behavior that must be assessed prior to market entry, not years after this unfortunate consequence has been documented retrospectively. Smokers who might have otherwise been inclined to try to quit, may latch on to a smokeless product bearing an "Anytime. Anywhere." or a "WHEN YOU CAN'T SMOKE" claim, and use it to perpetuate their smoking through the dual use of combusting and non-combusting tobacco. In fact, the United States Smokeless Tobacco Company expressed the view in their 2000 annual report that the dual use of cigarettes and smokeless tobacco "represents great potential for future expansion of the business" (UST, Inc, Annual Report, 2000, page 9). In the absence of public health-based regulation of these products, and well controlled studies of actual patterns of consumer use completed prior to market entry, we have no way of knowing whether this new generation of products will reduce exposure and risk in any meaningful way when used by smokers under normal or typical conditions of use. Nor do we understand the impact on quitting behavior amongst those smokers who otherwise would have achieved complete abstinence when they are exposed to the unsubstantiated claims of these novel tobacco products. Even more of a concern, we will not know what effect this marketing will have on the possibility of young people initiating tobacco use. The unfettered access to the marketplace for these products has created a massive, uncontrolled clinical trial, with commercialization and hefty promotion and advertising preceding a scientifically credible demonstration that there is adequate proof to support the marketing claims and expected public health outcomes of these products. Regulatory Approaches for Novel Tobacco Products: Recommendations The most appropriate way to assess the potential risks and benefits of these products is through a regulatory system that assures the public of comprehensive regulation of all tobacco products; a system where a public health-based regulatory agency evaluates products and claims before they enter the marketplace. As this Subcommittee goes forward with its consideration of the role of tobacco-based products in a harm reduction framework, we need to ensure that an appropriate degree of scientific and regulatory accountability is brought to bear on any tobacco products that purport to reduce exposure or risk. One way to achieve this accountability is by insisting that no product or claim should appear in the marketplace until it has been evaluated by an independent, public health-based regulatory authority. Such an agency, and we believe it should be FDA, should decide whether there is an adequate scientific basis to support whatever claims the manufacturer seeks to make. Whereas the tobacco-based products are carefully designed to perpetuate tobacco use, or at least could have that real world effect, in contrast GSK and other providers of treatment interventions offer quitting programs rigorously studied and evaluated for their safety and efficacy by FDA prior to appearing in the marketplace. We are proud of the collaboration we entered into with Congress, the FDA and the public health community in the mid-1990s to expand access and utilization of nicotine replacement therapies by marketing them as over-the-counter medications starting in 1996. (Centers for Disease Control and Prevention, 1997), (Shiffman et al., 1997), (Centers of Disease Control and Prevention, 2000a), (Keeler et al., 2002). We have been encouraged by the evidence that offering treatments directly to consumers can significantly increase utilization of these products to support quit attempts. Yet, we have not exhausted our opportunities to innovate in the area of tobacco dependence treatment through the use of pharmaceuticals and other public health interventions that expand utilization while also improving outcomes, as recent success in the area of quit lines have shown. We believe it should be the policy of our government to encourage sponsors to develop new indications and uses for current products, and to work with sponsors to accelerate development of a range of novel treatment products. GSK has a number of new products that offer the promise of more consumer acceptable formulations and regimens and a range of experimental drugs are in development within industry and academia. For instance, over-the-counter nicotine replacement therapy products are limited to up to 12 weeks of use as compared to six months or more under their former prescription status. Addiction experts have argued that the appeal and effectiveness of currently marketed treatments could be enhanced dramatically should we consider new uses and indications such as combination therapy, use of intensive behavioral interventions alongside pharmacotherapy, reduction of cigarettes alongside a gradual increase in medicinal nicotine administration, and use of NRT for relapse prevention and long term maintenance of cessation. Promising drugs and interventions like these should be fast tracked when judged by the FDA to qualify for such status. Finally, GSK welcomes scientifically validated and regulated claims for tobacco-based products. It is not our position that novel tobacco products cannot be marketed today under existing tobacco regulations or that it is unconceivable that such products might make a public health contribution. Our position is that any health claim, expressed or implied, should be scientifically demonstrated and reviewed by FDA before such claims are exposed to the most vulnerable within our society - those who have recently quit, are highly motivated to quit, or are tempted to begin smoking. For a marketplace flooded with unproven and unregulated health claims for novel tobacco products will not only undo years of progress in the tobacco control effort but also damage our capacity to bring even more effective and consumer accepted treatments to the millions of consumers who want and deserve meaningful improvements in their health status. Today half of ever smokers have become former smokers. Our challenge and yours is to ensure that successful quitters are not lured back to smoking and the vast majority of smokers who can and will eventually quit completely are not discouraged from reducing the harm of smoking to zero. As to the remainder of smokers who may not be able to quit, and we would argue that we have many opportunities yet before us to reduce this number further, we need to find interim and credible solutions to reducing harm to their health. The current cadre of novel tobacco products, if allowed to remain in the market absent scientific evidence of a positive health impact within the population, should nonetheless be prohibited from making implied or expressed claims of health improvement until such time as adequate proof and public health regulatory approval has been obtained. At GSK, we stand ready to assist the Subcommittee in any way that we can on these critically important and challenging questions of how to reduce the extraordinary death and disease toll caused by the use of tobacco products. Thank you for the opportunity to appear before you today. I would be happy to answer any questions that the subcommittee might have. ###
References
Centers for Disease Control and Prevention. (1997). Impact of promotion of the Great American Smokeout and availability of over-the-counter nicotine medications, 1996. Morbidity and Mortality Weekly Report, 46, 868-871. Centers of Disease Control and Prevention. (2000). Use of FDA-approved pharmacologic treatments for tobacco dependence. Morbidity and Mortality Weekly Report, 49, 665-668. Centers for Disease Control and Prevention. (2002a). Annual smoking-attributable mortality, years of potential life lost, and economic costs --- United States 1995-1999. Morbidity and Mortality Weekly Report, 51, 300-3. Centers for Disease Control and Prevention. (2002b). Tobacco control state highlights 2002: Impact and opportunity. Atlanta, GA: Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. Centers for Disease Control and Prevention. (2002c). Cigarette smoking among adults - United States, 2000. Morbidity and Mortality Weekly Reports, 49, 642-5. Food and Drug Administration. (1995). 21 CFR Part 801, et al. Regulations restricting the sale and distribution of cigarettes and smokeless tobacco products to protect children and adolescents; proposed rule analysis regarding FDA's jurisdiction over nicotine-containing cigarettes and smokeless tobacco products; notice. Federal Register, 60 (155), 41314-41792. Food and Drug Administration. (1996). 21 CFR Part 801, et al. Regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents; final rule. Federal Register, 61 (168), 44396-45318. Godtfredsen NS, Holst C, Prescott E, Vestbo J, Osler M. (2002). Smoking reduction, smoking cessation, and mortality: a 16-year follow-up of 19,732 men and women from The Copenhagen Centre for Prospective Population Studies. American Journal of Epidemiology, 156 (11), 994-1001. Institute of Medicine. (2001). Clearing the smoke: Assessing the science base for tobacco harm reduction. Stratton K, Shetty P, Wallace R, Bondurant S (eds). Institute of Medicine. Keeler TE, Hu TW, Keith A, Manning R, Marciniak MD, Ong M, & Sung HY. (2002). The benefits of switching smoking cessation drugs to over-the-counter status. Health Economics, 11, 389-402. Lynch BS, & Bonnie RJ. (Eds.). (1994). Growing up tobacco free: preventing nicotine addiction in children and youths. Washington, DC: National Academy Press. Shiffman S, Gitchell J, Pinney J M, Burton SL, Kemper KE, & Lara EA. (1997). Public health benefit of over-the-counter nicotine medications. Tobacco Control, 6, 306-310. U.S. Department of Health and Human Services. (2001). Risks associated with smoking cigarettes with low machine-measured yields of tar and nicotine. Monograph Number 13. U.S. Department of Health and Human Services. Public Health Service. National Institutes of Health. National Cancer Institute. UST Annual Report, 2000. U.S. Department of Health and Human Services. (1990) The health benefits of smoking cessation: A report of the Surgeon General. U.S. Department of Health and Human Services. Public Health Service. Centers for Disease Control. Center for Chronic Disease Prevention and Health Promotion. Office on Smoking and Health. DHHS Publication No. CDC) 90-8416.
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