Earlier this week, the New England Journal of Medicine chastised GlaxoSmithKline and Merck for monkeying with the integrity of Data Safety Monitoring Boards. Specifically, the journal ran an editorial citing the RECORD trial, which Glaxo touts as proof that its Avandia diabetes pill is safe, as an instance when the drugmaker “went around” the DSMB and the independent steering committee.

The editorial cites the US Senate Finance Committee report released earlier this year in which internal Glaxo emails indicate that Glaxo execs, not the trial’s independent steering committee, made the final decision to publish interim RECORD results (go here for a link to the Senate report and then page 3 and page 8). The NEJM published rhe data in May 2007, but was unaware of Glaxo’s “manipulations.”

A May 2007 email cited in the Senate report includes this passage: If “the steering committee are reluctant to publish - Frank and I will argue the case that there is a balance to be drawn between very negative press coverage and specific reassurance for the patients in the study. However if the SC believe that publishing interim data will fatally damage their ability to bring the study to a completion - Frank and I will bring that opinion with reasons back to GSK, before pursuing the line - that a decision has been made - live with it.”

Then there is the statement made in June 2007 by Moncef Slaoui, Glaxo’s R&D chief, before the House Committee on Oversight and Government Reform. That month, he told the committee in sworn testimony that Glaxo decided, “in concert with the RECORD study DSMB and steering committee and with the knowledge of the EMEA (European Medicines Agency) and the FDA, to conduct an unblinded safety interim analysis of the cardiovascular outcome RECORD trial.”

In response, a Glaxo spokeswoman sent us a statement saying the Senate report “does not address the decision to conduct the interim analysis; it only addresses the decision to publish those results. The allegations in the NEJM editorial, ‘Don’t Mess with the DSMB,’ about the conduct of the interim analysis of the RECORD clinical trial in May 2007 are false.

“The facts make clear that GSK consulted both the Data Safety Monitoring Board (DSMB) and the Steering Committee for RECORD prior to conducting the interim analysis. Specifically, on May 14, 2007, GSK consulted the chair and lead statistician for both the DSMB and Steering Committee, and obtained their consent to perform an unblinded interim analysis to help further inform about the risk of ischemic events in patients on Avandia. Only then was the interim analysis conducted. The RECORD Steering Committee and DSMB were directly involved in this decision and any suggestion to the contrary is demonstrably false.”

With respect to the separate step of publishing the results from the interim analysis, GSK believed it was important that this data be made available to the public, and discussed this with the RECORD Steering Committee. To protect the integrity of the study and the results of the interim analysis, the Steering Committee decided that it was appropriate to publish the results in a peer-reviewed journal.”