ENHANCE Study: The Thing That Wouldn't Leave...the Blogosphere

In response to criticism (mainly in the WSJ) that Harlan Krumholz, MD, unfairly monopolized Sunday's ACC panel discussion of the ENHANCE study, which recommended that Vytorin be relegated to last-resort cholesterol management, the Yale cardiologist fired back yesterday in a blog post to Pharmalot.

"We [the 4-physician panel] were asked to comment on the ENHANCE study and discovered over the course of several weeks of discussion that we had a clear consensus about the recommendations for practice. My comments reflected that consensus," reads an excerpt.

Others on the ACC panel, who have not yet chimed in publicly one way or the other, were Joseph Messer, MD, Rick Nishimura, MD, and Patrick O’Gara, MD, whose selection for discussion of the ENHANCE study at the ACC was questioned by Schering-Plough CEO Fred Hassan. However, criticism of the panel generally and that of Krumholz specifically are not limited to SP insiders like Hassan or chief medical officer Robert Spiegel. A Sanford Bernstein analyst reported to the WSJ that the panel discussion "was essentially not a panel discussion at all, but rather a monologue by Dr. Harlan Krumholz, who was very negative on Vytorin."

Another legitimate criticism from Hassan, a criticism which has nevertheless been cast in a negative light by Pharmalot's Ed Silverman, is the lack of allowed participation by the ACC audience to specifically question the ENHANCE results and the panel. Such an open forum would have (or, at least, should have) raised the issue of the missing or implausible data in the ENHANCE study and their effect on the trial's validity.

Image: The SNL Archives.