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Independents' Day

Study looked at all insulins, not just glargine

Your news article 'Study fuels glargine cancer debate', reporting a presentation by Dr Craig Currie at the EASD congress, contained some fundamental inaccuracies that cannot pass uncorrected.

Most importantly, this study did not at any point refer specifically to insulin glargine. It discussed the possible association between all insulins and cancer.

The article also misleads readers into believing this is a new study. The data is an extension to the THIN data published online as one of four registry studies in Diabetologia on 26 June. The conclusion of this specific study was that use of insulin analogues was not associated with increased cancer risk as compared with human insulin. The results remain inconsistent within and between all four studies, and no conclusion can be drawn regarding any possible relationship between insulin glargine and occurrence of malignancies.

The article claims 'in response to the trial's findings' Sanofi-Aventis would launch 'a new investigation', which is factually incorrect. No new investigation is necessary. Sanofi-Aventis has been consistent in its commitment to monitoring the safety of insulin glargine in close collaboration with regulatory authorities and scientific experts.

The EASD presentations do not change our understanding. Clinical studies covering more than 70,000 patients and data from over 24 million patient-years of experience show no association between insulin glargine and cancer - this is supported by a data review of 31 randomised clinical trials of insulin glargine, published online by Diabetologia on 15 September. The review, by PD Home and P Lagarenne, concludes: 'In these 31 RCTs, insulin glargine was not associated with an increased incidence of cancer, including breast cancer, compared with the comparator group.'

Finally, statements from scientific and regulatory bodies, including the EASD, EMEA, FDA and ADA, do not recommend patients should stop taking insulin glargine on the basis of the evidence in these studies.

From Dr Tony Whitehead, medical director, Sanofi-Aventis UK

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