Letters FDA on rosiglitazone

More on advisory committee decision

BMJ 2010; 341 doi: http://dx.doi.org/10.1136/bmj.c4868 (Published 07 September 2010) Cite this as: BMJ 2010;341:c4868
  1. David J Graham, medical officer1,
  2. Kate Gelperin, medical officer1
  1. 1Office of Surveillance and Epidemiology, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
  1. david.graham1{at}fda.hhs.gov

    Your readers may be interested in additional background concerning the recent US Food and Drug Administration (FDA) advisory committee meeting on rosiglitazone.1 In July 2007 a joint meeting of two FDA advisory committees voted 20-3 that rosiglitazone increased the risk of acute myocardial ischaemia and 22-1 that rosiglitazone remain on the market, without ever describing the drug’s benefits or explaining how they exceeded its cardiovascular risks.2

    In July 2010 the FDA convened the same committees to consider again the fate of rosiglitazone.3 In an unprecedented move, FDA’s Center for Drug Evaluation and Research (CDER), which originally approved rosiglitazone and has defended its continued marketing, invited not only the current members of these committees but also all members from the 2007 meeting, even though they were no longer active members of either committee. Of the 32 advisers who voted at the 2010 meeting, 16 (50%) attended the 2007 meeting, and 15 of them had voted that rosiglitazone remain on the market (one attendee was a temporary non-voting invitee).

    The addition of these former members substantially biased the results of the vote on whether rosiglitazone should be withdrawn from the market (table). Members voting for the first time were 4.4-times (95% confidence interval 1.1 to 17.0; P=0.01) more likely to vote that rosiglitazone be withdrawn from the market than were members who had voted previously to keep it on the market.

    FDA advisory committee vote on market withdrawal of rosiglitazone by whether adviser had previously voted to keep rosiglitazone on market

    View this table:

    By inviting these former members to participate in the 2010 meeting, CDER biased the outcome of the vote in favour of rosiglitazone remaining on the market. Had these former members not been included, the vote would have been 10 out of 17 (59%) in favour of rosiglitazone withdrawal, with an additional three in favour of severely restricted distribution.

    Notes

    Cite this as: BMJ 2010;341:c4868

    Footnotes

    • These are the views of DJG and KP and not necessarily those of the FDA.

    • Competing interests: None declared.

    References