AVANDIA:  TOO DANGEROUS TO STUDY?
Avandia v. Actos (TIDE) Trial

Medical journalist Shelley Wood recently discussed, in an article for heart.org, the controversy of the TIDE (Thiazolidinedione Intervention with Vitamin D Evaluation) trial, commissioned by the FDA to compare and contrast the safety of two diabetes drugs, Avandia and Actos. There has been evidence of a much higher risk of serious cardiac problems with Avandia in previous studies and there is a question of how informed the patients in the trial have been made of these risks.

The first informed-consent form was made when the trial was designed in 2008 and is no longer appropriate in the eyes of many experts. A February 2009 consent form was also deemed to be lacking sufficient warning of cardiac risks involved. The form simply said “[Avandia] might increase the chance of a heart attack… However, other studies have not confirmed this information.” A more recent, October 2009, form was found to be much more satisfactory by critics and reads “heart problems such as angina or heart attack have been reported in some patients who are taking [Avandia] in combination with insulin.” However some, including FDA Commissioner Margaret Hamburg, still feel that this wording is still not clear enough to the patients enrolling in the trial.

Several doctors have advocated for the study because they are curious to see what the results of the trial will be. Dr. Darren McGuire of the University of Texas Southwestern Medical Center stated that he hopes TIDE will continue because “I think it’s… legitimate to continue the head-to-head randomized trial, because I don’t think we know the answer.” However Dr. McGuire also stated that of the two, he only prescribes Actos because Avandia does not seem to have any advantage over Actos, which has sparked less safety concerns. Dr. David Juurlink of the University of Toronto believes that this curiosity is not an adequate reason for continuing the study, which he feels contains unethical safety risks. He stated, “I accept that there is uncertainty, but there sure are an awful lot of data to show that [Avandia] is less safe, and there is not a shred of data to suggest that it is safer. So given that, why go any further? And if this trial continues and goes to completion, it’s distinctly possible that that certainty- the proof that all existing data were in fact right- is going to be measured in lives.”
As of now, whether to continue the trial or not is scheduled to be discussed by the FDA and the Institute of Medicine this coming July.

Scott Levensten, Esquire, of the Levensten Law Firm, has successfully represented injured victims of harmful side effects for nearly 15 years. Mr. Levensten has a significant base of clients who suffered heart attacks and strokes on prescription drugs. If you would like Mr. Levensten to represent you or a loved one, please contact us through this site, or you may email Mr. Levensten at sdl@levenstenlawfirm.com, or call the firm’s toll free number (800)-510-1325.