GSK Communication With Trial Investigators

Several facts are left unclear in the New York Times article entitled "Glaxo Memo on Avandia Questioned." 

The FDA mandated the TIDE trial, and the Agency asked GSK to write a summary of a two-day Advisory Committee hearing (July 13-14) and the FDA's subsequent notification to GSK that the TIDE trial was being placed on partial clinical hold. The summary was directed to a very specific audience:  investigators (the doctors doing the trials), Institutional Review Boards and Ethics Committees that oversee the ongoing TIDE clinical trial with Avandia.

Specifically, the FDA asked: "Within one week, you must inform all investigators, institutional review boards (IRBs) and ethic committees involved in the TIDE trial of the new safety data/information presented at the FDA Advisory Committee meeting held on July 13 and 14, 2010.  Please also include information regarding the deliberations, recommendations and voting from the panel members regarding the specific questions posed at the meeting.  This information may be utilized by investigators and IRBs to update the informed consent document for patients currently enrolled in the TIDE trial.  In addition, a written summary of this information/data should be submitted to your IND file."

GSK agreed the letter was important for investigators so that they could inform patients in the TIDE trial about the Advisory Committee meeting.  GSK then prepared the letter, which the chair of the TIDE Steering Committee approved. The letter was not a general outreach to physicians.

The summary was to be brief (9.5 pages here) and sent quickly (sent within one week). To provide some context, the transcripts of the meeting total 934 pages. Written briefing materials for the committee had been posted by FDA online and the GSK letter alerted investigators to the documents and provided a link to available materials. Contrary to the NY Times report, the summary mailed by GSK provided full detail on the questions posed to the Advisory Committee and the vote on each.

The summary outlined presentations by FDA agency personnel, GSK and others as well as major discussion points. A brief summary--which is what was required--certainly cannot cover the entirety of the briefings or hearing presentations but both GSK and the chair of the TIDE steering committee agreed that the summary reflected the science and data discussed at the advisory committee meeting. A copy of the letter is available for public review.