Just a few years ago, researchers rarely identified industry sponsors of their clinical trials.
But when these conflicts of interest began to emerge, so did questions of bias. Now, as one critic puts it, we have “an orgy of disclosure.”
So, it was a bit surprising to see the reaction to a piece in last week’s issue of the
Annals of Internal Medicine suggesting corporate sponsorship may have introduced bias in the Jupiter study., That study concluded that statins are effective for primary prevention of heart attacks in patients with normal cholesterol but high CRP levels.
In a story in The Heart Wire on the flap, PI Paul Ridker of Brigham and Women’s Hospital notes that his corporate sponsorship is well known and that BWH owns the patent for the CRP test in question.
This is one of the most independent trials ever done. We had a truly independent DSMB, totally independent statisticians, and we structured this trial to be completely independent of the company.’
He also charged critics with “going after” Rory Collins, who chaired the data monitoring committee.
In the same story, Dr Steven Nissen of the Cleveland Clinic stood up for Ridker and Collins, calling the critical AIM paper “troubling and, frankly, offensive…” The authors, he said “spend much of their paper impugning the integrity” of Ridker and Collins.
Another website, CardioBrief, described two of the paper’s authors as member of “obscure, cult-like group of cholesterol skeptics.”
So, NNB checked in with the local author on the paper, John Abramson. He is not a member of the “cult” but is a clinical instructor at Harvard Medical School and the author of the 2008 Book Overdosed America.
He said no one should take personal offense when researchers raise questions about conflicts of interest.
I think it’s a smoke screen to cover up the real issue in the article that we wrote in the AIM, which is that the numbers that were reported in the NEJM don’t add up.
He believes an independent analysis of all of the data would answer many of the questions he and his group raise. But, that data is not available.
Data from commercially sponsored trials is treated as proprietary information, like the recipe for Coke. … That’s a major problem. .. Even though this data is privately owned, it functions as a public good in society. It is going to command public funds and it is going to dictate how people are treated. .. This trial is so important that the researchers and the sponsors, in good faith, ought to open up the data to independent analysis. I don’t mean just the calculated data— I mean the case reports from the individuals who had adverse events in the study. It’s like having a corporate financial report that the corporation doesn’t allow to be audited independently
He also notes that he’s not a member of the cholesterol skeptics group like his co-authors and believes that statins are useful.
I think people who have heart disease benefit from taking a statins… Statins also appear to benefit very high risk men who don’t have heart disease…… They certainly can’t paint all of us with the same brush.