CardioExchange Archive

July 26th, 2010

Questions for Sanjay Kaul about TIDE and Avandia

Sanjay Kaul, MD and Harlan M. Krumholz, MD, SM

CardioExchange’s editor-in-chief Harlan Krumholz discussed the TIDE trial on email with Sanjay Kaul, who was a member of the FDA’s advisory panel last week on Avandia. Here is a lightly edited version of their exchange. Krumholz: What is your response to the FDA announcement that it has placed TIDE on a “partial clinical hold”? Do you […]

---

July 22nd, 2010

Lessons Learned from 2 Avandia Panels

Larry Husten, PHD

In a perspective published online in the New England Journal of Medicine, Clifford Rosen, who was the chair of the 2007 FDA Advisory Panel that allowed rosiglitazone (Avandia) to remain on the market and also a member of the panel that met last week, writes about “lessons learned” from the extraordinary series of events involving […]

---

July 21st, 2010

FDA Halts New Enrollment in TIDE

Larry Husten, PHD

The FDA has halted new enrollment in TIDE (Thiazolidinedione Intervention with Vitamin D Evaluation), the controversial Avandia safety study, by placing the study on “partial clinical hold.” Patients already enrolled in the trial will continue to participate. The FDA said in a statement that it had instructed GlaxoSmithKline to “update investigators, institutional review boards (IRBs) and ethics committees […]

---

July 20th, 2010

Avandia Panelist Received Money from GSK

Larry Husten, PHD

One of the voting members of last week’s controversial Avandia panel received speaking fees from GlaxoSmithKline, the manufacturer of Avandia, according to news reports in the Wall Street Journal and Pharmalot. The FDA had previously said that there were no relevant conflicts for any of the 33 voting members of the panel. David Capuzzi, an endocrinologist at […]

---