1. Tobacco Harm Reduction: Perspectives of the Tobacco Control Community Kenneth E. Warner, Ph.D. Erika G. Martin University of Michigan School of Public Health Department of Health Management & Policy Supported by a grant from the Robert Wood Johnson Foundation

2. Abstract Problem/Objective. “Tobacco harm reduction” has received recent attention due to the tobacco and pharmaceutical companies introducing novel nicotine-delivery products, as well as the failure of traditional prevention/cessation programs to assist inveterate smokers. Many of these products remain unregulated, especially those produced by tobacco companies, and their role in reducing tobacco-related health risks must be elucidated. Assessing the awareness of and opinions on THR among members of the tobacco control community is an important first step toward this goal. Methods. A mixed-mode mail/web survey of knowledge, attitudes, and beliefs was sent to approximately 2800 attendees of the 2001 National Conference on Tobacco or Health. A follow- up telephone survey was administered to a random sample of non-respondents. Results. 70% of respondents indicated familiarity with THR. Sentiments toward THR were generally negative, and many respondents anticipated significant harm from its promotion. Responses differed by type of work (scientist versus activist), level of education, and primary focus (local/state versus national/international). The volume of "unsure" responses was not trivial, suggesting a need for more information. Conclusions. Due to the rapidity with which these products are being brought to market, the tobacco control community should strive to become cognizant of the issues raised by THR. Experience with low tar and nicotine cigarettes calls for caution in this area; however, there is also potential for positive public health benefit. Active dialogue on these issues should be an important component of tobacco control.

3. Problem Smoking prevalence in developed countries declines slowly and the death toll remains frighteningly high. The challenges of assisting the inveterate smoking population and the appearance of novel products on the market purporting to reduce the hazards of smoking has led to recent attention to tobacco harm reduction among smoking cessation leaders. It is unclear what grassroots advocates think about the topic. Clearly, this group will play a large role in determining the future role of harm reduction.

4. Survey Definition of Harm Reduction Some cigarette smokers are unable or unwilling to stop using nicotine. Tobacco harm reduction means decreasing total tobacco-related death and illness by encouraging these cigarette smokers to substitute other potentially less hazardous nicotine-yielding products. Examples include: –Cigarettes modified to remove one or more toxins. –Nicotine and non-nicotine pharmaceuticals. –Cigarette-like devices that heat rather than burn tobacco. –Nicotine lozenges. –Smokeless tobacco.

5. Methods Sample. A convenience sample consisting of the 2833 U.S.-based registrants for the 2001 National Conference. 67.1% adjusted response rate. Instrument. Mixed-mode mail/web survey administered between Oct. 2 - Nov. 19, 2002. Topics included: –Awareness of THR. –Perception of its present and future importance. –Support for regulatory policies pertaining to THR and conventional products, and assessment of whether Congress legislate regulation. –Perception of which, if any, THR products should be recommended by health care practitioners to inveterate smokers.

6. Methods Non-Response Survey. 200 non-respondents were randomly selected after the survey closed for a brief telephone interview to assess their eligibility and familiarity with THR, for use in the response rate calculation and response bias assessment. The adjusted response rate was calculated using the estimated percentage of non-respondents ineligible to participate. Most questions were constructed as 5-point Likert scales. Some categories have been collapsed in the data presentation.

7. Methods Responses for the following groups were compared. For each comparison, individuals indicating allegiance to both groups were excluded from the analysis. –Scientists versus activists. –Those focusing on local and/or state concerns and individuals with national and/or international interests. All analyses presented do not include “unsure” and “rather not answer” responses, except for THR familiarity. For this question alone, “unsure” responses were combined with negative responses. The significance level was set at p<0.05.

8. Demographics Age –<30 19.7% –31-50 55.6% –>50 24.7% Female 70.1% Race/ethnicity –White, non-Hispanic 80.5% –African-American 9.0% –Asian/Pacific Islander 4.2% –Am. Indian/Alaskan Native 2.7% –Other 1.0% Education –<Masters degree 40.9% –Masters degree 40.5% –Doctoral degree 18.6% Tobacco control involvement integrally related to paid employment 82.1% Significant tobacco-related volunteer efforts 71.0% Principal involvements with tobacco issues –Advocate/activist27.9% –Educator33.7% –Med. professional counseling 6.8% –Program admin./manager35.3% –Program staff21.3% –Researcher/scientist17.8% –Other12.4% Demographic focus of tobacco efforts –Youth/adolescents73.5% –Elderly14.0% –Women36.0% –Minorities45.4% –General population67.9% Geographic focus of tobacco efforts –Local66.3% –State62.0% –National29.2% –International 7.7%

9. THR Awareness 69.7% were familiar with the term “tobacco harm reduction” prior to receiving the survey.* Of those familiar with the term, –28.5% had first heard the term in the last year. –30.7% had first heard the term 1-2 years ago. –31.9% had first heard the term 2-5 years ago. – 8.9% had first heard the term greater than 5 years ago. * For this question, “unsure” and “no” responses were combined.

10. THR Awareness Main sources of information on THR included: scientific conferences (64.1%), professional journals (60.7%), conversations with non-medical colleagues (49.6%), media (30.7%), tobacco industry reports and documents (24.7%), and conversations with medical professionals or colleagues (24.5%). 42.9% said that THR currently receives “a fair amount” to “a great deal” of attention in tobacco control. 82.7% think that THR will receive “a fair amount” to “a great deal” of attention in 10 years.

11. Product Recognition * Cigarette-like devices. –Accord22.4% –Eclipse52.7% –Favor 5.9% –Premier30.2% Cigarettes with reduced carcinogens or low tar/nicotine. –Advance18.3% –Next 8.8% –Omni50.1% –Quest12.6% Smokeless tobacco products. –Ariva cigalets36.0% –Exalt 6.2% –Revel12.2% –Snus11.6% Novel nicotine products. –Likatine 3.0% –Nicotine water72.1% Pharmaceuticals. –Nicoderm94.1% –Nicorette96.4% Fabricated products (used as controls). –Cigems 3.8% –Hitex 0.3% –Viva 5.6% * Percentages reflect number of respondents indicating familiarity with each product.

12. Future Importance of THR Prevention. –12.1% believe THR will have larger role; 67.4% predict it will have a smaller role. Cessation. –26.0% believe THR will have larger role; 38.8% predict it will have a smaller role. Reducing ETS. –24.5% believe THR will have larger role; 47.5% predict it will have a smaller role. Comparison of THR and the following methods to decrease tobacco related health risks, ten years from now.

13. Future Importance of THR Reduced rate of smoking cessation. –49.3% agree; 32.1% disagree. Children experimenting with nicotine products. –48.4% agree; 34.4% disagree. Unintended negative side effects on health of users. –63.1% agree; 13.0% disagree Agreement and disagreement with the following possible negative effects of tobacco harm reduction.

14. Future Importance of THR Eventual impact of THR on the health of the American public. –26.4% anticipate a net benefit; 56.0% foresee harm. Health risks for individual smokers of smoking low tar and nicotine cigarettes versus full-strength filtered cigarettes. –20.7% perceive an increased risk to individuals; 10.4% think there’s a decreased risk. Impact on the collective health of Americans if low tar and nicotine cigarettes had never been marketed. –40.4% think U.S. health would have been better; 7.5% predict it would have been worse.

15. Government Regulation: Conventional Tobacco Products The government should… …regulate marketing techniques. 93.8% agree; 4.3% disagree …evaluate safety. 94.0% agree; 4.1% disagree …set excise taxes tied to level of risk to user. 75.2% agree; 13.0% disagree …regulate packaging, including size, design, placement of warning. 89.2% agree; 5.3% disagree …gradually phase nicotine content of tobacco products down to nonaddicting levels. 29.8% agree; 49.5% disagree

16. Government Regulation: Harm Reduction Products The government should… …set pre-marketing approval of health claims. 91.3% agree; 5.7% disagree …set product performance standards. 87.2% agree; 7.8% disagree …mandate pre-marketing approval based on significant reduction in health risk. 88.4% agree; 7.9% disagree …do post-marketing surveillance, banning products found to cause unacceptable health risks or attract children. 93.2% agree; 4.2% disagree …regulate marketing techniques. 90.4% agree; 4.9% disagree …set excise taxes tied to level of risk to user. 65.1% agree; 16.7% disagree

17. Likelihood of Government Regulation Likelihood of Congress authorizing one or more methods of regulating conventional tobacco products within the next 5 years. –29.8% likely; 49.5% not likely Likelihood of Congress authorizing one or more methods of regulating THR products within the next 5 years. –22.9% likely; 54.8% not likely

18. Recommendations to Smokers Support for medical professionals recommending the following products to smokers who cannot or will not quit. –Cigarettes that heat but do not burn tobacco. 10.0% in favor; 77.3% opposed –Conventional smokeless tobacco products. 6.2% in favor; 90.2% opposed –Very low nitrosamine smokeless tobacco products. 11.0% in favor; 81.1% opposed –Nicotine patches. 75.8% in favor; 17.5% opposed –Tobacco lozenges. 39.3% in favor; 48.0% opposed –Cigarettes with one or more carcinogens removed. 7.2% in favor; 87.2% opposed –Nicotine gum. 69.9% in favor; 21.6% opposed –Nicotine-free cigarettes. 17.2% in favor; 72.4% opposed –Low tar/nicotine cigarettes. 6.9% in favor; 89.0% opposed

19. Comparison of Activists and Scientists Scientists are more likely to be familiar with THR, and to be able to recognize specific products. Activists have a greater expectation of harm. Scientists are more likely to perceive an eventual benefit. Both groups support the listed regulations of both THR and conventional tobacco products. Activists are more optimistic regarding the likelihood of Congressional law authorizing any of the methods of regulation in 5 years. Activists are more likely to strongly oppose recommending several products for inveterate smokers.

20. Comparison of Local and National Level of Focus Those with a national/international level of focus are more likely to be familiar with THR, and to be able to recognize specific products. Those with a local/state level of focus have a greater expectation of negative unintended consequences. Both groups support regulation of THR and conventional tobacco products. Those with local/state interests are more optimistic regarding the likelihood of Congressional law authorizing any regulation in 5 years. Those with a local/state level of focus are more likely to strongly oppose recommending several products for inveterate smokers.

21. Limitations Conference registrants may not accurately represent the entirety of the tobacco control community. There may have been a response bias among respondents compared to non-respondents. The follow- up telephone survey provides evidence that those not responding were less likely to be familiar with THR. There is no “registry” of the U.S. tobacco control community. We believe that the conference participants constitute as good a representation of this group as is possible.

22. Conclusions A substantial proportion of the entire grassroots tobacco control community is unaware of THR. Although respondents do not perceive THR to be an important component of tobacco control today, they anticipate greater future attention on the topic, and many worry about its implications.

23. Conclusions While strongly supporting governmental regulation of both THR and conventional tobacco products, respondents do not anticipate Congressional legislation mandating such regulation.

24. Conclusions The gloomy outlook of the tobacco control community towards THR is supported by prior experience with low tar/nicotine cigarettes, also ostensibly less risky products. The debate over THR is almost certain to continue, fostered by the continued emergence of novel products.

25. Conclusions Although respondents do not anticipate regulation in the near future, the likelihood of such control will grow as the tobacco control community becomes sensitized to the issues and concerned about them enough to lobby hard for regulation.