Jack E Henningfield

I am going to put Dr Vocci on the spot. Frank, you are one of the coauthors of the Guidelines for medications development which tried to level the playing field. With what you have heard today, what do you think about harm reduction with respect to tobacco?

Frank J Vocci

In the opiate field, we have somewhat acquiesced with the idea of total abstinence for all opiate users. If we can get people into treatment, we know that a certain proportion will stop using opiates, but then there is a subgroup that will not, but will reduce their use. We have somehow stuck with them and have started to accept those patients more.

I think if you use that type of a strategy, you have to start looking at these partial responders as people who are possibly giving the best response that they can. If you are conducting clinical trials in smoking cessation, you could look at secondary indications, like reduction of use, because for every drug that produces cessation, there is going to be a subgroup with reduced use. This subgroup is probably embedded within the clinical trial. All you need to do is to analyse the data a little differently and do a secondary analysis. We have categorised these people originally as failures, and perhaps we just have to start thinking differently : if you can get a sustained reduction of whatever the determined magnitude is for a long enough period of time, you should be able to show a reduction in harm.

There is a tension developing between these types of proximal endpoint and some of the things I am hearing lately from Robert Temple at the FDA, who feels that perhaps we should be looking at different endpoints. The other day he made the analogy of the congestive heart …