The suspension follows the suspension of the TIDE trial in India, July 14, at the request of the Indian government which was concerned about the drug’s safety following revelations reported by The New York Times , documenting how GlaxoSmithKline concealed drug-induced heart attacks and falsely claimed the drug’s safety./10diabetes.html and http://www.ahrp.org/cms/content/view/710/9/
The TIDE trial is inherently unethical: it is designed to compare Avandia, a drug that has been shown to significantly increase the risk of heart attacks–and death–to a competitor drug, Actos, whose safety record shows no such serious risks.
GSK argued before an FDA advisory committee that a head to head trial would prove that Avandia does not cause heart attacks after all, and that all the evidence against the drug was "not scientific."
GSK’ record of deceptive, illegal drug marketing tactics are a matter of public record. Those tactics and its defective drugs–including Paxil and Avandia–resulted in the deaths of thousands of people–even maiming infants in the womb.
That GSK attempted to buy time for its defective drug, Avandia, until its patent runs out, is not surprising.
What is more disturbing is that a combined FDA advisory panel of medical "experts" (33 in all) did not reject GSK’s argument, and did not object to the TIDE trial to go forth–even as they voted overwhelmingly (29 to 3) to add warnings (7), to restrict the drug’s sales and add warnings (10), to withdraw the drug from the market (12).
The failure, by a supposedly objective group of academic medical doctors and scientists, to suspend an immoral trial which was designed in the knowledge that patients would be put at risk of cardiac arrest for marketing purposes, speaks volumes about the state of American medicine.
Vera Hassner Sharav