Behind The Curtain: That Secret Vytorin Panel
3 CommentsBy Ed Silverman // January 11th, 2008 // 8:00 am
You may recall that Schering-Plough and Merck caused a ruckus two months ago when they provided an overdue update to a long-delayed clinical trial of their blockbuster cholesterol med, which was being compared to Zocor. The reason for the flap - the drugmakers changed the endpoint and appointed an anonymous panel of experts to review the techniques used to measure the results.
In fact, the lead investigator, John Kastelein, wasn’t privvy to the decision, Forbes reports. It’s “shocking” that Kastelein would not be party to discussion of the ENHANCE trial, Harlan Krumholz, a cardiologist at Yale University, tells the mag. “There should be a scientific committee that’s independent running a study. He should be taking a leadership role.”
Of course, changing endpoints is a scientific no-no and the move caused outrage at a time when drugmakers are under increasing scrutiny for the way they handle clinical trial data. Merck and Schering-Plough quickly backtracked and decided to leave the endpoint alone, but by then, the episode damaged their reputations and prompted a congressional investigation.
But who is on that secret panel? Forbes has the list. It’s not a wide-ranging committee of experts on clinical trials, but instead a group with expertise on studying the arteries with imaging technology, the mag writes. Four are top experts in the field of using ultrasound to take pictures of artery plaque.
The panel: J. Robin Crouse and Gregory Evans of Wake Forest University, who conducted a study using Crestor, a rival cholesterol drug from AstraZeneca; Orloff, medical director of Medpace, a company that conducts clinical trials for drug firms and the former head of the FDA division that handled the approvals of Zetia and Vytorin; Michiel Bots of the Julius Center for Health Sciences and Primary Care University Medical Center Utrecht, Netherlands, who has worked on similar studies and James Stein of the University of Wisconsin, who has conducted studies on the treatment of heart disease in patients with HIV and how various substances affect artery walls.
Hank
The further this gets, the worse it looks. That may or may not be accurate. But MSP folks seem to keep digging a deeper hole.
Roy M. Poses MD
Also, it appears that the “independent” panel really wasn’t. Three panel members had financial ties to Merck, or both Merck and Schering-Plough, in addition to their service on the panel. See this post on Health Care Renewal:
http://hcrenewal.blogspot.com/2008/01/who-decided-to-change-outcome-variable.html
BPW
Independent is all relative. While they were independent of the ENHANCE study, they were all paid consultants for MSP.
I simply have a very tough time believing that Dave Orloff would have anything to do with recommending that MSP change the primary endpoint. He used to head up the Metabolic/Endocrine division of the FDA and knows what regulatory agencies expect. he also knows what is appropriate scientific conduct and what is not.