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FDA’s Partial Hold on Unethical Diabetes Drug Trial Does Not Do Enough to Protect Patients

Statement of Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group

The Food and Drug Administration (FDA) has gone only half-way in stopping the unethical TIDE study by halting the recruitment of any new patients. To allow the experiment to continue at all is a major breach in the FDA’s obligation to protect people in clinical trials. In May of this year, we wrote to the FDA urging a complete cessation of the TIDE trial. In late 2008, we petitioned the FDA to ban the diabetes drug rosiglitazone, better known as Avandia.

By stating that “Patients already enrolled in the trial will be allowed to continue to participate,” the FDA is failing to protect the more than 1,100 people already enrolled in the trial from the needless damage that will occur to those randomized to get rosiglitazone instead of pioglitazone, commonly known as Actos.

As the Institute of Medicine told the FDA last week, when new information concerning a drug becomes available, the participants need to be informed. How many of these 1,100 people would drop out of the study if they were told, for example, that an FDA advisory committee voted 21 to 3 (with 9 unsure) that the heart risks of rosiglitazone are greater than those of pioglitazone? This compounds the previous lack of informed consent about the two key facts – that an expert committee of the American Diabetes Association unanimously concluded that Avandia should not be used for treating diabetes and that there has been more than an 80 percent decrease in prescriptions for the drug.

By failing to completely stop the TIDE trial and to ban the drug, the FDA is not only guaranteeing that the 1,100 patients in the TIDE trial continue to be subjected to an unacceptably dangerous drug, but also hundreds of thousands of people will continue to use the drug in this country.

 To read Public Citizen’s letter to the FDA, sent in May, to stop the TIDE trial, visit: https://www.citizen.org/our-work/health-and-safety/articles/letter-urging-fda-halt-rosiglitazone-avandia-trial.