In the wake of questions about GlaxoSmithKline’s Avandia clinic trials, the Austin American-Statesman‘s Ana Cantú talks about her own experience in a different GSK clinical trial five years ago. Her column isn’t long, but she manages to capture the pharmaceutical giant’s desperation and the pressure put on participants. It helps that Cantú was, in some ways, a fulcrum for the study’s success.
I don’t want to spoil the story, but it all revolves around the requirement that seven of the 20 participants complete the study to garner sufficient data for submission to the FDA. After 13 participants dropped by the wayside, a sick and unhappy Cantú found herself on the bubble. She needed a medical authorization to drop out and still receive the $4,800 she was due for her participation, but the physicians in charge of the study were under immense pressure to keep her around and maintain that all-important quorum.
In the end, there’s a reason she refers to it as the “most miserable month of my life,” but at the time Cantú had only scratched the surface of the significance of her participation. Now, her reflections are revealing.