Reply: Dietary acrylamide and cancer risk: additional data on coffee

Abstract

Sir, We appreciate the comments of Drs Hagmar and Tornqvist (2003) on our article assessing dietary acrylamide and cancer risk (Mucci et al, 2003). We take this opportunity to clarify some issues and to present data from additional analyses. We undertook the original investigation in light of claims by the Swedish National Food Administration that acrylamide in foods could have global impacts on cancer incidence rates. In spite of the potential limitations of the study design, our data are reassuring that acrylamide seems unlikely to be responsible for a major fraction of these cancers. As stated in our discussion, however, additional data are needed before a global assessment of any risks of dietary acrylamide can be undertaken in relation to other cancer sites and neurological diseases. The reliance on toxicological risk assessment models employed by Hagmar and Tornqvist may be questionable. Estimates of human cancer risk were extrapolated from animal models, given doses of acrylamide several fold higher than those to which humans are exposed (International Agency for Research on Cancer (IARC), 1994). We think that animal data must be generalized to humans with caution. This sentiment is reflected by IARC (2002) who considers an agent as definitely carcinogenic to humans when there is sufficient evidence from studies in humans (i.e. epidemiological evidence) and only ‘exceptionally’ in other situations. The authors present evidence from power analyses on the substantial sample size needed to detect an effect of acrylamide on human cancer risk. Notwithstanding the limitations of the risk assessment models, the authors determined an expected relative risk of 1.05 for the highest vs lowest dose. An effect estimate of this size is almost impossible to determine in any observational study. Indeed, not even a randomised clinical trial would have the power to detect this effect. The scientific methods to study such a small effect currently do not exist, and beg the question of how to best proceed to address the question of acrylamide and cancer. In addition, we must ask whether a relative risk of this size warranted the public health alarm that was generated when the findings of acrylamide in food were first announced.