www.Pharmalot.com writes that some physicians are telling Heartwire that the TIDE trial, which is supposed to involve thousands of patients, should be stopped, in part because informed consent forms may not reflect the most up-to-date Avandia safety info, an issue that FDA commish Margaret Hamburg alluded to in a recent letter to US Senator Chuck Grassley, who is investigating Glaxo and its handling of Avandia.
Heartwire goes on to report that some trial sites appear to be rethinking their participation. But Jeff Probstfield of the University of Washington in Seattle, who is the national leader for TIDE's US sites, says the most recent info sent to researchers and patients is more comprehensive. "There is no new information in our view that suggests there is anything different from what we knew all along, and that is that there is a need for a very good randomized trial to determine the relative benefit or risk of this drug. This is our opportunity to get this answer," he tells heartwire. "I don't know exactly whose agenda this is, but it's not making things easy right now."
In other words, the bad press is making it harder to enroll patients. Probstfield continues that this trial represents a chance to "get it right." Of course, as another doc wryly notes while wearing his 'cynical skeptic's hat,' the longer the trial continues, Glaxo is better off, since more pills will be sold. In the end, Jurrink argues, the outcome will be measured in lives.