The Indian government has ordered GlaxoSmithKline to suspend 19 trials for its Avandia pill due to recently released studies showing potential heart problems (seehere and here), according to CBS News. This is the latest blow to Glaxo, which has been struggling to enroll patients in the TIDE trial that the FDA required in order to compare cardiovascular risks between Avandia and the rival Actos pill.
However, a growing chorus of bioethicists and doctors say the trial should be halted, given that Avandia is linked to cardiovascular problems (see here and here). In fact, FDA commish Margaret Hamburg asked the Institute of Medicine to explore this issue and a preliminary guideline was discussed at this week's FDA advisory committee hearing (look here).
"The DCGI (Drug Controller General of India) has written to Quintiles, the clinical research organisation (CRO) running this trial in India, requesting that it be placed on hold with immediate effect," according to a Glaxo spokesperson. "Accordingly, all sites in India participating on the TIDE study were informed of the hold status by letter on Wednesday, June 30, 2010. The reason stated by the DCGI was recent publication of a cohort observational study and a meta analysis concerning rosiglitazone. GSK, the principal investigators of TIDE and the CRO involved will provide the DCGI with any further data or information it requires in advance of a final decision on this study being made."
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At least ONE country got it right!!