From the Erasmus Medical Center committee report regarding Schouten O, Boersma E, Hoeks SE, Benner R, van Urk H, van Sambeek MR, et al. Fluvastatin and perioperative events in patients undergoing vascular surgery. N Engl J Med 2009;361:980–9.

“Despite the absence of informed-consent forms and source documents, and despite the theoretical possibility that researchers could have by-passed blinding, the witness statements give the Committee reason to believe that this project, including the informed-consent procedure, was conducted largely according to protocol. Selective examination of the database revealed a few minor protocol deviations. Finally, the Committee is of the opinion that withdrawal of the relevant publication [NEJM 2009] would be of limited social and clinical relevance. Various other studies have demonstrated the beneficial effect of administering statins pre-operatively — which has since become standard practice.

“All in all, the Committee sees no reason to inform the journal, co-authors, and those who funded the study.

“As the Committee believes serious breaches of protocol to have been unlikely, and any adverse consequences of participation in the study to be implausible, the Committee recommends that patients or their representatives should not be informed other than through a general public announcement.

“The Committee considers that further fact-finding with regard to this project is not indicated.”

The full committee report is available at www.erasmusmc.nl/5663/135857/3664573/3397899/report_summary_investigation_integrity.