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  1. Jack E Henningfield
  1. National Institute on Drug Abuse, Addiction Research Center, Baltimore, Maryland, USA

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I’m going to take off where Dr McGinnis left us to introduce this afternoon’s session. I think it was encouraging that he mentioned that tobacco dependence treatment was efficient and might possibly even be effective, and I think his sobering appraisal of effectiveness is a challenge that we should take, and a challenge we have to confront with data. We’ve been hearing about data this morning; we’re going to hear more data this afternoon on the effectiveness of treatment.

As a biomedical researcher in the Public Health Service, I’m really excited. I think that what we have in this area is a biomedical research triumph. A figure we should keep in mind is that, untreated, about 2.5% of smokers quit per year. That’s a very low baseline against anything else that we can do, and we can do a lot better.

And when we talk about minimal counselling, that’s not random minimal counselling. The kind of things that Drs Ockene, Orleans and others were discussing this morning, are structured minimal counselling approaches that have come out of research. Nicotine- replacement therapies are another major benefit of biomedical research, this is an area in which we’ve already seen that we can do a lot but the challenge is how to do more.

And that brings us to what I think should be the key questions that we should keep in mind during this session, and these are: How should nicotine replacement fit into a national health care system, whether it comes about next year or the year after? How much behavioural therapy and what kind of behavioural therapy should it be combined with? Which should be the primary therapy: nicotine replacement or the behavioural therapy? Which should be the adjunct? These are some of the issues that we’re going to be discussing this afternoon.

We’re really fortunate to have this panel and Dr Sachs to make a presentation. I’m going to introduce the panel first.

Dr Dorothy Hatsukami is Associate Professor in the Department of Psychiatry and Adjunct Associate Professor in the Department of Psychology at the University of Minnesota. She’s the director of a tobacco research laboratory. She and John Hughes, along with several colleagues, have really nailed down the course and the role of nicotine replacement in the treatment of this problem.

Dr Cynthia Rand is at Johns Hopkins University, and she has been very actively involved in one of the sites in the long-term Lung Health Study. She has an enormous range of practical clinical experience and also has attended to some of the very tricky issues in smoking cessation, like weight gain, gender- specific issues, issues in women, and what happens when people are on nicotine replacement for four or five years, as some of them were in the Lung Health Study.

Dr John Slade is not only an outstanding public health servant, he’s also a friend and colleague that I’ve worked with on a number of papers, and one that I’ve enjoyed disagreeing with as much as agreeing with. He has petitioned the Food and Drug Administration (FDA) on a range of issues and is what I consider to be a very reasoned critic of misuse of nicotine replacement. I am very pleased that he agreed to come here this afternoon.

Dr Daniel Spyker is from the FDA and is therefore one of the people on the increasingly ‘hot seat’ on a lot of these issues that we’ve been discussing. I have come to admire the way they’ve been working in that division and I think we are alll aware of the role the FDA, and Dr Spyker has been doing.

This brings me to our speaker, who’s going to set the scene for us. Dr David Sachs is the Director of the Palo Alto Center for Pulmonary Disease Prevention. He has been a major researcher in the area and has worked on a variety of nicotine replacement therapies and modalities. I think he has been one of the people that’s helped elucidate the role of nicotine replacement in behavioural therapies, and he has been cognizant of the risks and benefits of replacement therapies and how to maximise the benefits.