The Morven Dialogues on Tobacco, Nicotine and Alternative Products Harm Reduction. M a y a n d R at i o n a l A p p r o a c h

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1 T h e C h a n g i n g E n v i r o n m e n t o f T o b a c c o, N i c o t i n e, a n d A lt e r n at i v e P r o d u c t R e g u l at i o n: D e v e l o p i n g a M o r e C o h e r e n t a n d R at i o n a l A p p r o a c h M a y The Morven Dialogues on Tobacco, Nicotine and Alternative Products Harm Reduction Tobacco Report Revised-Print.indd 1 12/3/2012 4:12:12 PM

2 This Report documents the results of a dialogue sponsored by the Institute for Environmental Negotiation, University of Virginia, at Morven, a retreat setting outside of Charlottesville, Virginia. A dialogue is an opportunity for people with diverse perspectives to exchange views, learn from one another, and promote wider understanding of those diverse views. It is not intended as a consensus-building exercise or a negotiation. This Report does not represent a consensus or a set of agreed upon recommendations, nor does it imply directly or indirectly the endorsement on the part of any individual of the Report itself or of any components of the Report. The purpose of the dialogue was to continue an informal conversation about a variety of important issues related to tobacco, nicotine and alternative products harm reduction regulation. The purpose of this Report is to offer insight into the range of views of participants. Tobacco Report Revised-Print.indd 2 12/3/2012 4:12:13 PM

3 MORVEN DIALOGUES 3 Table of Contents Executive Summary... 4 Part I : Background A Brief History... 6 Why the Morven Dialogues... 7 Covening the May 10-11, 2012 Dialogue... 9 Part II - The 2012 Morven Dialogue Opening the Dialogue Focused Dialogue on Four Questions: (1) Terminologies & Definitions (2) Core Principles for Research Funding (3) Strategies for Supporting the Availability of Lower Risk Consumer Acceptable Products (4) Regulatory Structure Needed to Oversee Tobacco, Nicotine, & Alternate Product Regulation Reflections on the Focused Dialogue Concluding the Dialogue (Day Two) Part III - Facilitators Notes Facilitator Acknowledgments and Observations Funding Tobacco Report Revised-Print.indd 3 12/3/2012 4:12:13 PM

4 4 MORVEN DIALOGUES Executive Summary On May 10 and 11, 2012 a diverse group of 30 individuals met at the University of Virginia s Morven, a retreat setting outside Charlottesville, Virginia, for a dialogue titled The Changing Environment of Tobacco, Nicotine, and Alternative Product Regulation: Developing a More Coherent and Rational Approach. The group spent the first day discussing four themes: Better defining the terms that are used in today s rapidly changing tobacco, nicotine and alternative products environment; Supporting the availability of lower risk and consumer-acceptable tobacco, nicotine and alternative products, and whether this would allow companies to move away from the manufacture, sale and marketing of cigarettes The kind of regulatory structure that would best regulate all tobacco, nicotine and alternative products Ways of implementing the Core Principles (and related items) from last years dialogue concerning Corporate Funding for Tobacco, Nicotine and Alternative Product Harm Reduction Research Day two of the dialogue focused on two themes. No vote was taken or consensus statement sought for these issues, as participants differed about the need for or practicality of these ideas as well as ways that such needs might be fulfilled. 1) The need for the United States to develop an effective, consistent and workable sciencebased tobacco, nicotine and alternative products harm reduction program, which might serve as a model for other countries. 2) The need for an independent, appropriate body to be identified (or created) and funded to develop a comparable risk assessment of all tobacco, nicotine and alternative products that is based on the most up to date science and takes into account both the individual and the general population. A number of participants stated that dialogues of this sort that bring together conflicting Tobacco Report Revised-Print.indd 4 12/3/2012 4:12:13 PM

5 MORVEN DIALOGUES 5 interests in candid, civil explorations of key issues need to continue. For this dialogue, participation and sponsorship were sought from the full spectrum of views about issues of regulation and harm reduction. Although highly diverse in numerous ways, the dialogue was unable to attract a segment who have taken a public stance against harm reduction strategies that promote smokers switching to potentially lower risk tobacco/nicotine products, or who are unwilling to discuss these policy issues with members of the tobacco industry. Many participants urged continued efforts to include an even wider spectrum of stakeholders than was represented at Morven, including those currently opposing harm reduction strategies. Tobacco Report Revised-Print.indd 5 12/3/2012 4:12:13 PM

6 6 MORVEN DIALOGUES Part I: Background A Brief History Since the US Food and Drug Administration obtained jurisdiction over tobacco products in 2009, the environment of tobacco, nicotine and alternative products has been in a state of flux. Although these changes began almost 10 years ago, they have accelerated during the last three years. Technology, research, innovation, new product development and even competition have altered the discourse to a point Today, a large and expanding gray area has developed, revealing shades of differences among the spectrum of manufacturers and products as well as in the tobacco control and public health arena, where there are differing views and opinions about what the future holds. where it is challenging if not impossible to avoid considering this spectrum of products within a single regulatory framework. What a new framework that reflects the emerging reality of the growing array of products might look like, not only in the United States but internationally as well, remains to be seen. In spite of the complexity of the 2009 statute, its numerous congressionally mandated requirements, and its sometimes outdated and confusing provisions, the Food and Drug Administration (FDA) has made a concerted effort to engage all stakeholders. By holding workshops, hearings, listening sessions, and individual meetings, the FDA is providing a forum for a more extensive governmentsponsored discussion of a spectrum of issues. However, the FDA is limited in what it can do. In order to have a meaningful discussion about the many challenges and opportunities faced by players in the tobacco and nicotine environment, the players need to find a way to engage in a different manner than they have over the last four decades a period that can best be described as polarizing and without trust. Some have described these years as black and white, with the tobacco industry perceived as wearing black hats and the public health community perceived in white hats. Today, a large and expanding gray area has developed, revealing shades of differences among the spectrum of manufacturers and products, as well as in the tobacco control and public health arena, where there are differing views and opinions about what the future should hold. This complex and historically contentious Tobacco Report Revised-Print.indd 6 12/3/2012 4:12:14 PM

7 MORVEN DIALOGUES 7 environment calls for greater engagement and candid dialogue on a host of issues, which will require a shift away from what has been called the tobacco wars. However, for many stakeholders, including industry (which means not just cigarette manufacturers but pharmaceutical companies as well), the tobacco control community and the broader public health community, acceptance of change does not come easily. Many have expressed unwillingness to engage those with different and often conflict views about these issues. Why the Morven Dialogues? Virginia has long been regarded as the first tobacco state, where the production and manufacturing of tobacco and tobacco products trace their roots. United States patriots such as George Washington and Thomas Jefferson helped to establish tobacco as the nation s premier cash crop for nearly two centuries. Virginia is also the place where tension and conflict among various tobacco and tobacco interests began to surface and be recognized, suggesting a need for greater engagement of all involved. For many years, there has been a significant absence, in both the public and private sectors, of a safe haven for parties to come together and discuss the controversial issues surrounding tobacco and nicotine. Many in the tobacco control community have maintained a policy not to engage with Big Tobacco, and for many years tobacco industry stakeholders perceived public health as the enemy whose aim was to destroy their livelihood. In the mid-1990 s the Institute for Environ- mental Negotiation (IEN) was asked by a coalition of forward-thinking public health interests to bring parties together in order to In recent years, with the passage of the tobacco statute giving FDA oversight over tobacco, there has been a growing need for revitalizing and enhancing dialogue in both the private and public sectors. confront head-on some of the tobacco and health issues. Called the Southern Tobacco Communities Project, this effort focused on bringing together public health advocates and tobacco producers to talk about the future (manufacturers were invited initially but declined to participate). Through the auspices of the IEN, and with great trepidation and anxiety on the part of many, some in the Tobacco Report Revised-Print.indd 7 12/3/2012 4:12:14 PM

8 8 MORVEN DIALOGUES public health and tobacco grower communities of key tobacco producing states sat down together to talk about the future. The results were both surprising and significant. These two camps, which had a long history of distrust, were eventually able to agree on a set of Core Principles that provided support for both FDA oversight of tobacco as well as for a tobacco buyout that would help the tobacco producing communities transition out of the tobacco business while maintaining farm livelihoods. This willingness to accept change helped pave the way for legislation that would emerge from the US Congress several years later. Since the grower/public health dialogues, attention turned more and more to Congress. In recent years, with the passage of the tobacco statute giving FDA oversight over tobacco, there has been a growing need for revitalizing and enhancing dialogue in both the private and public sectors. discussion to include industry participation and to cover all forms of corporate funding (i.e. pharmaceutical/biotech funding, as well as funding from traditional manufacturers of tobacco products). After a very candid, intense, but civil two days of dialogue, a set of Core Principles was produced and released in October All of the participants in the dialogue signed off on the document titled Core Principles Concerning Corporate Funding for Tobacco, Nicotine, and Alternative Harm Reduction Research. The group that met at Morven in 2011 also generally agreed that the dialogue should broaden and continue. Today the IEN is continuing its role in providing the safe haven where stakeholders and experts can engage in a civil dialogue about the important issues related to tobacco, nicotine, alternative products and harm reduction. In March 2011 the Institute for Environmental Negotiation convened a group of some two-dozen individuals of diverse backgrounds to a dialogue titled Corporate Funding of Tobacco, Nicotine, and Alternative Products Harm Reduction Research. For several years the tobacco control community had engaged in discussions about whether or not, and, if so, under what conditions, tobacco industry funding for research should be accepted. Industry participation in those earlier discussions was prohibited. However, in an effort to build on these discussions, the March 2011 dialogue at Morven broadened the Tobacco Report Revised-Print.indd 8 12/3/2012 4:12:14 PM

9 MORVEN DIALOGUES 9 Convening the May 2012 Dialogue For a dialogue of this type to be effective at encouraging diverse and active participation, careful consideration needed to be given to the makeup of the group to allow for both productivity and safety. One criterion for an invitation was whether a prospective participant was open to the possibility of tobacco, nicotine, and alternative products harm reduction being used as a public health strategy. Other general, more subjective criteria included seeking a diverse set of experiences the candidates might have to offer and whether they would participate in both a candid and civil manner. representing organizations that they had long considered as enemies. Ultimately, the invitees made their own decisions about whether to attend. Participants were asked to cover their own costs, but IEN provided funds to support travel and accommodation to anyone requesting assistance. Some of those invited knew each other, some knew of each other, and still others were connecting for the first time. The invitation list included people based in the United States as well as internationally. All participants in the March 2011 Morven dialogue concerning corporate research funding were extended invitations to attend the May 2012 dialogue, and a number did attend. Those invited were asked to attend as individuals and to check their egos and organizational hats at the door. IEN was aware that, of others invited, many might not be able to attend for a variety of reasons. More than a dozen indicated a desire to attend but could not because of work-related obligations, year-end academic obligations or family conflicts. Others felt uncomfortable about talking to people Tobacco Report Revised-Print.indd 9 12/3/2012 4:12:14 PM

10 10 MORVEN DIALOGUES Part II: The 2012 Morven Dialogue Opening the Dialogue On May 10, 2012, some 30 people gathered at Morven, a retreat setting outside Charlottesville, Virginia that is managed by the University of Virginia Foundation. The meeting was facilitated by Frank Dukes, Director of the Institute for Environmental Negotiation (IEN) and Tanya Denckla Cobb, the IEN s Associate Director. The topic of the two-day dialogue was The Changing Environment of Tobacco, Nicotine, and Alternative Product Regulation: Developing a More Coherent and Rational Approach. Director Dukes and Associate Director Denckla Cobb provided opening remarks including a review of the agenda and the processes that would be used for the meeting. They emphasized the importance of ensuring that the meeting was taking place in a safe haven where all would be able to participate. They recommended that a variation of the Chatham House Rule would be employed, encouraging people freely to report their individual experiences and opinions without attributing comments to any other person or group. A meeting summary would be distributed that would include the substance of what was discussed but that would not attribute opinions or arguments to any particular individuals, unless it was germane to the subject (e.g., a formal presentation) and only with approval of those participants. Nor would it claim consensus or disagreement unless participants themselves decided to do so. The outcome of the dialogue was, accordingly, in the hands of the participants. Frank reminded people that the dialogue was not intended to be a negotiating session or take the form of a conference. He also reiterated that the dialogue was conducted under the sole auspices of the Institute for Environmental Negotiation. Dr. Richard Tubb, past White House physician and participant in the March 2011 Morven Dialogue, gave engaging preliminary remarks about the importance of substantive dialogue in the tobacco and nicotine arena, in which he portrayed himself as a relatively new player. He was followed by Susan Winckler, President and CEO of the Food and Drug Law Institute (FDLI), who also welcomed the participants and provided some of her views on the importance of the dialogue as well Tobacco Report Revised-Print.indd 10 12/3/2012 4:12:14 PM

11 MORVEN DIALOGUES 11 as the parallel and complimentary role the FDLI intends to play. Following these remarks, participants introduced themselves and had the opportunity to offer preliminary aspirations and expectations for the meeting. Just prior to the first morning break, Scott Ballin, consultant to the Institute for Environmental Negotiation, provided thoughts on the overall topic of the convening and cited examples of successful dialogues as evidence that this effort was both appropriate and necessary given the dynamic tobacco, nicotine and alternative products environment. He noted that previous dialogues have been facilitated by the Carter Center, Georgetown University (along with FDLI), the IEN, FDLI, and the FDA. There is a need for greater engagement and discussion around the tobacco issue in order to move beyond the climate of confrontation that sometimes pervades the tobacco debates. Following the break, Jim Solyst presented on the principles of regulatory science as applied to tobacco, nicotine and alternative products policy and regulation. The meeting was then opened up for general discussion, observations and questions. Participant comments focused on the notion that the current regulatory framework is in need of adjustment to reflect the changing field, and also reflected an openness to the need for dialogue. Statements below reflect individual participant perspectives and do not reflect any consensus. There is a need for greater engagement and discussion around the tobacco issue in order to move beyond the climate of mindless confrontation that sometimes pervades the tobacco debates. There is a need for leadership to make this happen. The FDA is perceived by some as being inconsistent and lacking a logical system of regulation. The statute needs review. The FDA appears to be more focused on meeting its statutory objectives than on having a thorough discussion about strategy for the future. Given the challenges set by the statute and its timelines, the CTP is actually doing a good job at what it needs to do. There is a need to discern fact from fiction so that actual facts can be used inform policy decisions. Dialogue can benefit not only those seen as having opposing views, but also those Tobacco Report Revised-Print.indd 11 12/3/2012 4:12:14 PM

12 12 MORVEN DIALOGUES with seemingly similar views who may gain new knowledge as well. We should keep in mind that there are a greater number of smokers in the international community than in the United States. Business reality underscores a contradiction that attends a company with a profit mission that includes selling cigarettes while at the same time trying to promote harm reduction products. One participant expressed the hope that this contradiction would disapprear in the future. It is important to recognize that different products are in various stages of development and life cycle. In order to promote more informed decision-making better information needs to be disseminated to the public at large. The FDA is new to the regulation of tobacco and will proceed slowly with respect to low-risk tobacco and nicotine products. Other groups might be utilized to enhance discussion and influence policy decisions. When the FDA and other governmental agencies state that no tobacco product is any less harmful than another, this contradicts common sense. Unlike the United States, the United Kingdom is moving toward a position that some nicotine products are more acceptable for long-term use than are cigarettes. Some in the public health community believe that if harm reduction products are endorsed, then industry should in turn agree to manufacture only those products. There is a concern that children and adolescents who try harm reduction products will then move to using cigarettes; however, more stringent regulatory controls over cigarettes could remedy this worst-case scenario. Focused Dialogue on Four Questions Before breaking for lunch the facilitators reviewed how the afternoon breakout sessions would be conducted. Four breakout sessions would be held with everyone given the opportunity to participate in each discussion. The four breakout sessions were framed by the following interrelated questions: Terminologies and Definitions: How can we better define the terms that are used in today s rapidly changing tobacco, nicotine and alternative products environment? Do Tobacco Report Revised-Print.indd 12 12/3/2012 4:12:14 PM

13 MORVEN DIALOGUES 13 we agree that terms need better definition, and if so, what process is needed for us to reach better definitions? Strategies for Supporting the Availability of Lower Risk Consumer Acceptable Products: How can we support the availability of lower risk and consumer-acceptable tobacco, nicotine and alternative products? Would this allow companies to move away from the manufacture, sale and marketing of cigarettes? Which comes first, the chicken or the egg OR both? Regulatory Structure Needed to Oversee Tobacco, Nicotine and Alternative Product Regulation: What kind of regulatory structure is needed that will provide a more uniform, coherent, fair and effective system for regulating all tobacco, nicotine and alternative products? Are there existing models and ideas, including from other countries that would inform our system? Core Principles for Research Funding: How can we move forward in implementing the Core Principles (and related items) from last years dialogue concerning Corporate Funding for Tobacco, Nicotine and Alternative Product Harm Reduction Research? As is evidenced by the individual comments captured from each session (see below), the discussions were informative, educational, thought provoking, lively and civil. 1. Terminologies and Definitions This breakout session invited discussion on the often confusing terminologies used in today s tobacco, nicotine and alternative products environment. The intention was to determine whether and how there might be greater clarity, understanding and use of terms. Rather than actually seeking to define these terms, the dialogue hoped to focus on developing ideas for a process by and through which parties could seek agreement for more consistent use. First, through discussion, a number of participants observed that terms are often not being used consistently. They also suggested that some terms are used in different contexts to mean or imply very different things, and that this is confusing. Lastly, they argued that it would helpful to find ways to move forward toward more rigorously defined and mutually understood terminology. No agreement was reached on a specific process or way forward, but numerous ideas were put forward to this end. Participants considered who needs to be included in a process for reviewing terms, and their responses suggest that the process should include a broad range of people with differing opinions and perspectives, and particularly should include reaching out and involving more diverse stakeholders. By the end of this discussion, some argued that the best approach would be multi-pronged: i.e., a mix of congressional oversight, a dialogue and discussion among NGOs and public health community, and movement by the FDA. Statements below reflect individual partici- Tobacco Report Revised-Print.indd 13 12/3/2012 4:12:15 PM

14 14 MORVEN DIALOGUES pant perspectives and do not reflect any consensus. Definitions would resolve confusion: Definitions are important because they will help determine what a product is and how it will be regulated. There is fundamental confusion by the public, policy makers, consumers and even those in tobacco control, about what nicotine is and its effects and dangers. There is a need to educate the press to use terms correctly and without bias. Definitions also need to be in tune with statutory/regulatory definitions in order to hold up in a court proceeding. The lack of consistently used terms has resulted in public confusion and altered perceptions that are not reality-based. Working with other nations is key to developing some global consistency. Definitions would be practical and even helpful for the consumer and general public: There is a general misunderstanding of how nicotine relates to and/or is different from smoking and the use of other products. An approach to definitions that applies a truly objective public health focus is the goal. Definitions should provide clarity for the public in relation to achieving a public health goal. For example, a view that states all tobacco is bad for the consumer, without differentiating products, is in fact not supporting the public health goal. Tobacco harm reduction and substitution are terms that should be used and understood by the general public in the United States, as is happening in the United Kingdom. Just because people use the Washington Beltway does not mean that many drive enjoy driving on that road; many would prefer a better route. (I.e., just because many people smoke cigarettes, doesn t mean they wouldn t prefer a less harmful alternative.) Seventy percent of smokers have regrets about using cigarettes and want to quit smoking. In order to do so, they need a menu of options. Harm reduction equates to health care costs reduction, especially in Medicare and Medicaid. If this point is made, considerable attention would be attracted to the cause. Specific issues that are related to the need for definitions: E-cigarettes and other hybrid products need to be separated from more traditional products made with tobacco leaf. The medical community seems to currently advise against long-term nicotine use. The way statistics are used can influence how terms are viewed and interpreted by Tobacco Report Revised-Print.indd 14 12/3/2012 4:12:15 PM

15 MORVEN DIALOGUES 15 the public. Biased statistics and research are not helpful. There is often a deliberate misuse of terminologies and definitions for political and ideological purposes, which causes confusion. Some people will always enjoy smoking, so banning cigarettes is not a feasible option. What should we do with respect to longerterm use of nicotine products? The FDA seems stuck on how to proceed on this issue. Risk refers to individual impact/choice, while Harm refers to societal impact. Statutory definitions need to be weighed against public health goals. Models and ideas for ways to create more functional definitions: One model might be to look at how food claims are done, where there is a direct correlation between the claim and information provided and the level of science available. The FDA seems to be recognizing the overlap between tobacco activities and nicotine activities. This creates an opportunity for oversight and more open discussions. There is need for greater public involvement including specifically users of tobacco products. There is need for health care providers to be involved in the discussion. The public and consumers need to be in the conversation so they can influence the terms that should be used and encourage people on both sides of the fence to move towards agreement. The tobacco control statute is overly complex and seems to have the effect of being focused on protecting cigarettes. There needs to be an oversight hearing by Congress to review the statute and invite all of the industry players and stakeholders to testify so that all input can be taken into account and decisions made about the direction of regulations and how terms will be defined and used. Oversight by Congress and others should be consistent for both tobacco and nicotine. Stakeholders that express uncertainty and confusion need to be a part of the process if they are to buy into the definitions. FDA regulation provides a venue to create better definitions. A bottom-up approach to looking at these issues has been helpful. By taking a step back to look at everything as a nicotine delivery product, it becomes possible to evaluate products; then decisions could be made about which products should be promoted more than others, and what should be explained or disclosed about each. Can the example of opiate-methadone Tobacco Report Revised-Print.indd 15 12/3/2012 4:12:15 PM

16 16 MORVEN DIALOGUES treatment be used in considering harm reduction nicotine products? Food and alcohol are regulated, not banned; should tobacco similarly be regulated for public health outcomes but not banned? Specific definitional questions that need resolution: What is a tobacco company? Does this term include any and all manufacturers that produce products containing tobaccoderivatives, or does the term refer to Big Tobacco companies that market more traditional products? What is a tobacco product? Is it anything that contains tobacco? What do we mean when we talk about cessation? Some refer to smoking cessation, while others to tobacco cessation or nicotine cessation. How should components of a product be regulated? Does regulating a battery of an e-cigarette overstep regulatory boundaries? This is not a new challenge for just tobacco but exists in other areas as well (drugs, devices, foods etc.). Can the smokeless product description be used to encompass all of the noncombustible products? Or do we need to define terms even within this category? 2. Core Principles for Research Funding (Follow-up to the March 2011 Morven Dialogue) This breakout session invited participants to consider next steps that might be taken towards the implementation of the Core Principles defined at the March 2011 dialogue. Some participants echoed the discussion of the 2011 dialogue, reiterating that companies should be able to give gifts/grants to researchers as long as there are appropriate protections and no strings attached to the gifts. However, a number of participants recognized that the concept of credibility means different things to different players. While industry may not see credibility as an issue, researchers see it as an issue as it may tie their hands in many ways. Still, some participants did reiterate the goal of the Core Principles, which is to protect the independence of the research institution and thereby ensure the credibility of the research. With general support that it is critical to have an oversight mechanism in place for any research, the question remained: what mechanisms might be used to achieve this? Participants spent significant time discussing potential models for protocols that would create a strong fire-wall between funders and researchers, to protect the independence and credibility of the research. One model noted by some participants is the Duke University system, and more recently the UVa system both of which lay out provisions in advance and require donor agreement. Research institutions are familiar with using conflict of interest protocols in many areas, including in the pharmaceutical area. Participants also discussed the potential involvement of the FDA, specifically noting Tobacco Report Revised-Print.indd 16 12/3/2012 4:12:15 PM

17 MORVEN DIALOGUES 17 that the same system used for other regulated products could be used here. For example, many of the same strategies for handling food could be adapted for tobacco. Also, the FDA might set up models to work through the office of Lawrence Deyton, and many models that already exist outside of the FDA s Center for Tobacco Products (CTP) could be used as templates. The idea of using a third-party, raised during the 2011 dialogue, was discussed in more detail. One approach could be to write the terms of the protocol agreement up front and then have a third uninterested party review the agreement to verify that the terms have integrity for the work being done. The key question is, how do you keep money from influencing researchers? There might be joint agreements between parties for mutual topics of interest. Alternatively, multiple parties might give money to the FDA to contract a third party researcher. On the research side of the coin, there is need for research centers that are specialized in tobacco and nicotine, which would keep costs down by mitigating the reinvention of previous work. On the other side, there is need for an organization that can track and monitor research and make information available. Statements below reflect individual participant perspectives and do not reflect any consensus. Battelle Memorial Institute Research, which could be contracted by the FDA to do the objective research. However, its board has said that it will not work with industry. A university could receive a gift from a corporation and hire an outside firm to monitor the research. Could the Society for Research on Nicotine and Tobacco (SRNT) oversee research? The International Prevention Research Institute (IPRI) could be used. The Reagan/Udall Foundation will be examining regulatory scientific issues for the FDA. How do you keep money from influencing researchers? There might be joint agreements between parties for mutual topics of interest. Alternatively, multiple parties might give money to the FDA to contract a third party researcher. Concerns about the how to achieve the desired goals were also expressed. For example, companies may not be willing to turn over the reins or provide research funding to bring a particular product to market if they have no control over the research. Such a requirement would likely produce a formal legal fight. There is a key difference between research involving a generic or broad topic Tobacco Report Revised-Print.indd 17 12/3/2012 4:12:15 PM

18 18 MORVEN DIALOGUES that is of mutual interest to company and researcher, which is uncontroversial, as opposed to product-specific research being handed over to an outside firm, free of oversight by the company. Pharmaceutical companies can test their own products. Now that the regulatory system is in place, this will need to happen for tobacco products. Tobacco industry should be on the same footing as the pharmaceutical industry. In response to these concerns, a number of participants noted that there is considerable need for research to fully bring harm reduction products to the market, and that there needs to be a differentiation between product development research and basic research. The new regulatory environment allows for this type of change to take place. Statements below reflect individual participant perspectives and do not reflect consenus. A scenario that raises issues of research integrity is work that involves specific data obtained from industry. Is an e-cigarette company considered a tobacco company? How might the answer affect research? The tobacco industry is unorganized on this issue, which underscores a lack of leadership for generating solutions. Participants also discussed specific criteria and ideas for an oversight mechanism: Transparency: A fully transparent process for research is needed. Also, all companies (manufacturers of tobacco or pharmaceutical products) need to make research available online to enable others to replicate it. Inclusion of Scientific Interests: An independent research forum could be established to bring all of the scientific interests together. This effort would be less about advocacy and more about scientific needs. Public engagement: Could a virtual environment be used to engage the public on these issues and as a forum for developing the ideas more fully? Continued Funding: Renewal grants should not be a part of this type of research, given the issues that can arise. 3. Strategies for Supporting the Availability of Lower Risk Consumer Acceptable Products This breakout session invited participants to discuss the chicken and egg issue of harm reduction. Individual comments are summarized below. Many public health stakeholders conceptually support the idea of harm reduction but worry that it may function as an industry tactic comparable to the development of so-called low-yield cigarettes. They believe that the industry cannot be trusted and that there need to be actual demonstrable actions (including acceptance of product regulation) before they can consider supporting a harm reduction approach. Tobacco Report Revised-Print.indd 18 12/3/2012 4:12:15 PM

19 MORVEN DIALOGUES 19 On the other hand, industry is reluctant to abandon its legal and profitable cigarette business until it sees a path forward for developing lower-risk products that would actually be available in the marketplace. Discussion in this session focused on ways of addressing this dilemma. The American experience with light cigarettes has left many public health advocates very cautious about the possibility that new, lower risk products may be perceived as safer than cigarettes when they really are Good, unbiased science is going to be critical. not. Organizations such as the American Cancer Society, among others, urged people to switch because it was initially believed that so-called light cigarettes were safer, which in fact has not been the case. Thus, many public health advocates believe that there remains an unknown level of risk of attracting current non-smokers to these tobacco products. The availability of lower risk products thus might increase rather than reduce the overall harm from tobacco products. There are also some who have prohibitionist views who recommend against the use of any and all tobacco, no matter what the relative risks are, and for whom no form of harm reduction short of prohibition is acceptable. For others who advocate harm reduction, every cigarette that you do not smoke because you are using a less harmful alternative is a measure of a positive change. But because smoke-free tobacco products currently have limitations on what can be said in labeling and advertising, many people believe that there is no advantage to using those products. That situation does not seem to be in the public health interest. There are real differences in risk among products, especially between noncombustible products and cigarettes, but that information is not being communicated. With regulatory oversight in place, some argue that we can avoid the problems of the past, where claims could be made without evidence. But who is going to provide leadership to move forward without repeating the past? In addition to public health and manufactures, there are regulators who can help pave the way. We need more forums and opportunities for people to talk about how to move forward. Statements below reflect individual participant perspectives and do not reflect any consensus. There need to be incentives to prompt manufacturers to change. Good, unbiased science is going to be critical. Smokeless consumption continues to rise in the US, while smoking is declining. One idea might be to include relative risk inserts in cigarette packs. Does awareness equate to action? If people are/were aware that smokeless is less harmful, will they switch? Tobacco Report Revised-Print.indd 19 12/3/2012 4:12:16 PM

20 20 MORVEN DIALOGUES 4. Regulatory Structure Needed to Oversee Tobacco, Nicotine and Alternative Product Regulation For decades the tobacco issue could be framed in black and white terms. Today, however, product regulation, technology, innovation, competition and new entrants into the market place have collectively changed the landscape of debate. The tobacco, nicotine and alternative products environment will continue to change, in some instances rapidly. As a consequence, we The current elephant in the room is the fact that, with a presidential election on the horizon, the NGOs do not seem motivated or willing to dialogue or to accept new ideas and strategies. need to find a new avenue forward that will reduce disease and death caused by the use of harmful tobacco products. This breakout session invited participants to discuss what a more rational regulatory framework might look like, given these changes, and to discuss how to move this objective forward. Statements below reflect individual participant perspectives and do not reflect any consensus. Many in the tobacco control movement and even federal regulatory agencies promote a tobacco free society (not just a smoke-free society ), yet the FDA authority to regulate products transfers some legitimacy to compliant manufacturers. Should the goal continue to be to rid the country of tobacco, or by contrast to shift tobacco products as far down the risk continuum as possible? One participant noted that the enemy should be seen as someone who tries to cheat on the rules. We should focus our attention more on whether or not products meet regulatory specifications and less on the identity of the manufacturer. How should the FDA deal with all tobacco containing products? Right now the focus is on reducing all advertising and preventing all tobacco use. There is a lack of a guiding philosophy on tobacco and nicotine harm reduction, which results in increased chaos and confusion in the marketplace. The FDA is unlikely to initiate any change on its own. It requires significant external consensus building. The current statute is lacking in any real harm reduction strategies. The bar has been raised so high in section 911 that innovation for new product development is discouraged. Section 911 also requires post market surveillance, which will take time and also sets a high bar. Should warning labels and other information be modified according to science? Currently, it appears that the FDA considers them to all have the same risk. FDA does not seem Tobacco Report Revised-Print.indd 20 12/3/2012 4:12:16 PM

21 MORVEN DIALOGUES 21 to be developing a regulatory structure that includes a real harm reduction policy other than the modified risk provision. Ignoring the IOM Clearing the Smoke report, there are no incentives for any manufacturer to develop new lower risk products. This reinforces the continued use of higher risk products. The FDA is not taking cigarettes off the market in the US; nor are regulators banning cigarettes in Europe. Someone needs to do a risk assessment of tobacco, nicotine and alternative products so that we might base all regulations on that assessment. Information and claims on products should be based on science and the intended use of the product. Statements below reflect individual participant perspectives and do not reflect any consensus. Some measure of intentionality is necessary, but how might we determine and measure intentionality? (E.g., if a product is intended as a smoking cessation product, does it actually achieve this? If a product is intended as a harm reduction product, does it actually achieve this?) Biomarkers for certain diseases make it virtually impossible to identify risk. Is this intentional? There needs to be reasonable regulation of e-cigarettes. How should this compare to nicotine gum, which is a medicinal product? Is there or should there be an expectation that a novel or modified risk tobacco product would be subject to less rigorous regulation? This will depend on the claims and how it might be classified. Why is there no real desire on the part of many to see new products on the market? A single change in a manufacturing process or method can completely change a smokeless tobacco product s classification. There is a desire to see a regulatory agency look at different products in different classes and regulate them based on risks, thereby applying greater regulation to cigarettes and less to other products. Could this actually happen? The FDA has a strategic work plan focused on cigarettes and smokeless products, but in the future it will inevitably incorporate all products. The inhaler might be the best alternative to the use of cigarettes. Bring all nicotine and tobacco under the same regulatory umbrella. Everything should be based on a scientific understanding of the risks and relative risks in relation to how products are used. This discussion has significant implications internationally as well as in the United States. The current elephant in the room is the fact that, with a presidential election on the horizon, the NGOs do not seem motivated or willing to dialogue or to accept new ideas and strategies. Tobacco Report Revised-Print.indd 21 12/3/2012 4:12:16 PM

22 22 MORVEN DIALOGUES Participant Reflections on the Focused Dialogue Following the four breakout discussions, in which all participants were able to contribute to all four questions, participants were invited to comment on the first day s efforts. A number of people s comments reflected a sense that the focused discussions had been helpful to air different perspectives on specific topics, and that helpful ideas had been put forth. Themes emerged around the need for leadership, the desire to be able to provide consumers with accurate information about relative risk, and an interest in focusing more on the nicotine itself. More specific individual comments included the following: Maybe there should be a dialogue on nicotine, itself, that includes all the products. Should we support putting new nicotine products on the market if they are relatively harmless but still addictive? Need for Leadership The environment is so unstable and unpredictable that leadership is essential. People have different expectations of federal agencies, which are often understaffed and underfunded. The public wants agencies to do more than they are capable of doing. CTP must provide some leadership, but others also must collectively lead and identify new leaders Accurate Information for the Consumer How can we get relative risk information into the hands of the consumer? How can the agency help advance this goal? We need a public health policy that actually promotes public choice through the dissemination of truthful information. The withholding of information can be just as misleading and deceptive as tobacco companies past efforts to deceive the public with misleading advertising. Are there possible First Amendment issues in restricting truthful speech? What is the tradeoff if we introduce harm reduction products? If a great product comes out that is acceptable to consumers, is the risk acceptable that there may be a small number of non-smokers who will use the product? How can we calculate risk? Policy We should have a national tobacco and Tobacco Report Revised-Print.indd 22 12/3/2012 4:12:16 PM

23 MORVEN DIALOGUES 23 nicotine policy that was based on the federal government conducting a scientific and transparent risk assessment of each product. NRT (nicotine) is the safest tobacco-derived product. Pharmaceutical companies are going to continue to make it difficult for any new products to come on the market. Because of the low success rate in quitting using NRT, could NRT be seen as a gateway for relapse? We need products that actually satisfy the user. A tobacco harm reduction policy should include NRT. Maybe there should be a dialogue on nicotine, itself, that includes all the products. Should we support putting new nicotine products on the market if they are relatively harmless but still addictive? Concluding the Dialogue (Day Two) The second day began with the facilitation team inviting the full group to reflect again on the previous day s activities. General observations and comments seemed clustered in three areas: Engagement with the opposition has tremendous value for all parties concerned, even if a specific agreement does not result. Dialogue in a safe-haven environment does in fact work and has value. The dynamically changing regulatory environment ushers in a new day with substantial opportunities for serving public health objectives. This dialogue is proof of the opportunities, but there needs to be more discussion on many levels. We need to transcend rhetoric and embrace discussions that will educate all stakeholders and experts. There are many topics that could be the subject of mini-dialogues involving varying numbers of people. It would be helpful to have invitees and participants understand up front what the parameters, criteria, and conditions are for funding such dialogues. Absence of that information can create mistrust for some who perceive rightly or wrongly that the meeting is being influenced by external sources. (Note: See Part III outlining the process that was undertaken, the reasons why, and the details that were spelled out in the letter requesting contributions to fund the dialogue. While these conditions were carefully spelled out to all potential contributors, the IEN will also let nvitees to future dialogues know what process will be followed earlier. As we noted earlier, Tobacco Report Revised-Print.indd 23 12/3/2012 4:12:16 PM

24 24 MORVEN DIALOGUES there could be a mini-dialogue on this topic, similar to what was done at the first Morven meeting, in order to determine and recommend criteria for any organization, conference, or meeting that accepts funding). Consumers and Tobacco Farmers Two presentations followed this general discussion. These presentations were made in order to give participants a better understanding of the importance of two groups consumers and tobacco farmers that are often overlooked in the discussions related to tobacco, nicotine and alternative products harm reduction. The first presentation focused on the consumer. In her presentation, Elaine Keller argued that consumers and the general public do not have adequate access to accurate and truthful information. She cited as an example the fact that an overwhelming majority believe that all tobacco products carry the same risks. Many consumers erroneously believe that nicotine is the agent that causes cancer. Only about 6% of the 20 million smokers who try to quit will succeed in the long term, and Keller argued that users need to be provided with other lower risk alternatives. There needs to be a more sustained effort to educate the public and consumers about the risks and relative risks of products in the market place. The second presentation focused on tobacco agriculture and producers in particular. Arnold Hamm provided the group with a brief history of the tobacco program, including information about why cooperatives got started and how the area of production has changed in part due to the globalization and competition of tobacco production. He noted that the regulatory environment that we are now entering will change the way in which growers and companies do business. Regulated products will have to meet very specific criteria, which will in turn impact production. Supply security will likely be a challenge for tobacco companies in the future as many growers may leave production in the face of more complex regulation. Following these presentations the remainder of the second day was devoted to general discussions about where the participants might go next. Several themes emerged around the need for engagement of a broader range of stakeholders, as well as an interest in policies for harm reduction and establishing a risk continuum. Statements below reflect individual participant perspectives and do not reflect any consensus. Engagement of a broader range of stakeholders It is disappointing that a number of invited participants chose not to participate, particularly those not known for supporting tobacco harm reduction. This group is imbalanced with those who are supporters Tobacco Report Revised-Print.indd 24 12/3/2012 4:12:16 PM