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I agree with Yano that scientific integrity should be maintained and researchers be free from pressure from commercial and campaigning interests. I disagree that I have caused any “distortion of scientific findings” or “misrepresentation and misappropriation” of results, serious charges which I will show are unjustified. To clarify the situation I will start with the history preceding the study.
In 1981 Hirayama reported an increased lung cancer risk in non-smoking women married to smokers.1 Following this I demonstrated random misclassification of smokers as non-smokers, coupled with smokers tending to marry smokers, leads to an observed increased risk even when environmental tobacco smoke (ETS) has no effect.2,3 The tobacco industry then agreed to support a study in England of this “misclassification bias”, using cotinine to validate smoking, which was reported in 1987.4 I also reviewed evidence on misclassification,5 revealing the lack of useful data in Japan, where cultural differences might affect reporting of smoking.
Several tobacco companies therefore decided to fund a study there. The protocol, drafted by Proctor and discussed with me, included two major phases. …
Competing interests: Peter Lee is a long term consultant to the tobacco industry.
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