Friday, July 30, 2010

The Jupiter Study Dust-Up

When the Jupiter study researchers published their results about Crestor (rosuvastatin) in 2008, this is what they had to say about certain elements regarding the study and its effects on heart disease:

Results showed a true benefit in the rosuvastatin group; there was a 44% lower risk of a first cardiovascular event. Regarding the secondary endpoints -- each component of the combined primary endpoint -- and the subgroup analyses also indicated a substantial risk reduction in cardiovascular events for those patients who were treated with rosuvastatin. As for the absolute risk reduction: because most patients were relatively healthy, it was relatively small.

Why this detail? To talk about the current conflict of interest-related dust-up in the recent Archives of Internal Medicine article.

The Jupiter trial involved 17,800 people and pitted Crestor vs placebo to see if the statin reduced the risk of heart disease in those with high levels of CRP, despite their normal levels of dangerous cholesterol. The FDA, which expanded Crestor’s use this year to people with high levels of CRP and other factors, apparently had no problems with the Jupiter study.

In a FiercePharma story, the Archives authors question the validity of the results from the 2008 study, wondering aloud why the trial was stopped nearly two years into it. The study authors more than suggest there was conflict of interest here because 9 of the 14 Jupiter researchers were financially involved with AstraZeneca, which paid for the Jupiter study. “The possibility that bias entered the trial is particularly concerning because of the strong commercial interest in the study,” the Archives authors write.

"The trial was financially supported by AstraZeneca," says spokesman Chris Sampson in the FiercePharma story, "but AstraZeneca played no role in conducting data analyses and had no access to un-blinded trial data."

It was an independent monitoring board that stopped Jupiter prematurely. The Archives researchers say it was never made clear what the predetermined benefit to one group over the other, was. They also argue that there were too few deaths to be able to say that it was the statin that should have all the scrutiny.

The lead Jupiter researcher told Time that the study population was healthier than other populations, and the study would have had to go on for a long time to “document a difference in heart-related death rates.” The Archives authors “suggest it would have been better to let the trial continue, and find out.”

It strikes us that these authors raise some old issues that were around in 2008. For one thing, the study’s principal author, Paul M. Ridker, is a co-inventor of the patents on the inflammatory markers, but his employer, Brigham and Women’s Hospital, holds the patent. 

It also strikes us that the FDA’s recent action to approve Crestor for otherwise healthy individuals with high CRP levels is not going to hurt other statin manufacturers.

It’s one thing to question the data soon after a study is out; it’s another thing to malign reputations two years after the fact. There’s no call for it. 

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