GSK is having serious problems recruiting patient volunteers to participate in a hotly contested clinical trial of Avandia, reported the Wall Street Journal today.
Two sites in the U.S. recently have withdrawn from the study due to poor enrollment. Several previous studies have linked the diabetes drug to an increased risk of heart attack. Critics of the Avandia trial, called TIDE, claim it is unethical because the drug already has been connected to dangerous cardiovascular side effects.
Glaxo responds that diabetes patients participating in the TIDE trial are advised of all possible Avandia side effects before signing required informed consent forms. The drug company contends that the safety problems remain unproven.
It has begun adding Avandia trial sites outside the U.S.. Dozens of new locations were opened last month in developing nations, where participants may not be aware of the safety questions surrounding the drug. GSK says of them were approved by local regulators and ethics overseers.
To read the April 20, 2010, Wall Street Journal article about Avandia and the TIDE trial, click here.
Things haven’t gone well since Jama issued the reform call to overhaul the medical approval process for drugs like Avandia. Is it any wonder that people are reluctant to be testing subjects for a drug with this kind of reputation?