Journal questions independence of key Crestor trial

Did financial ties to drugmaker AstraZeneca (NYSE: AZN) prejudice researchers in the pivotal trial that showed its cholesterol fighter Crestor prevented heart disease? An article in the new Archives of Internal Medicine raises that question, pointing out that nine of the 14 researchers who ran the Jupiter study had financial relationships with AstraZeneca. The lead researcher, moreover, is co-holder of a related patent and could see higher royalties from wider use of the drug, Bloomberg reports.

The Jupiter study attracted lots of attention in 2008, when researchers presenting at the American Heart Association's annual meeting said that five years of Crestor use by seemingly healthy people could prevent 250,000 cardiovascular problems. That data aided AstraZeneca's push to broaden Crestor use to anyone at risk of heart disease, even if cholesterol levels are normal.

The trial was so positive that AstraZeneca stopped the study early, saying it had "unequivocal evidence" that Crestor prevented death better than placebo in people who had no existing heart disease. But now, the Archives piece questions that decision, saying that "inconsistencies" in the data should have prompted officials to keep the trial going.

FDA, however, has praised the study as "exceptionally well conducted," and no less a pharma critic than Dr. Steve Nissen of the Cleveland Clinic has said, "Jupiter was a meticulously performed trial." AstraZeneca defends the study--and denies any undue influence on the researchers. "The trial was financially supported by AstraZeneca," spokesman Chris Sampson tells Bloomberg, "but AstraZeneca played no role in conducting data analyses and had no access to unblinded trial data."

- read the Bloomberg story
- get more from Time magazine
- see the Los Angeles Times piece