From: Harry Lando
To: John R. Polito
Date: April 10, 2002

Re: U.S. Guideline: NRT recycling, nicotined placebos, deception

Thank you for your communication on the US Guideline - Treating Tobacco Use and Dependence. I have been delayed somewhat in responding because I felt that your lengthy letter deserved careful consideration. Even now, I have not had an opportunity to study your letter as closely as I would like. One immediate reaction and suggestion is that you should communicate your concerns more widely if you have not already done so. This would (and should) include a letter to the editor at least of a major medical journal and also a communication to Michael Fiore who chaired the guideline panel (I assume you have already done this).

I think we were limited in looking at just actual published literature. You raise a large number of points that deserve a careful response and to which I do not have time to fully respond myself. Certainly you are right that the performance of some placebo groups are dismal, although it never crossed my mind that pharmaceutical companies might have intentionally doctored placebos to reduce their effectiveness. I could see the possibility that those who participate in these trials tend to be very hard core smokers and perhaps that those who seek drug and actually receive placebo might tend to fare very poorly.

My own career commitment has been to behavioral methods and I continue to believe that these are critically important. In my opinion there has been too much reliance on seeking the magic (pharmacological) bullet. We also know that medications in the absence of behavioral programs and support are less effective and this is especially likely in an OTC context. I appreciate many of your concerns.

I would hope at least in the research and treatment groups that there would be an openness and receptivity to these concerns as well. As a member of the guidelines panel, I can say that I was sometimes frustrated by the limits of the published studies that served as the basis for our report.

Again I would encourage you to continue to communicate your concerns and to get them into a public forum.

Regards,

Harry Lando