Dr. Bob Goldberg on much ado about data …
In another example of how the once respected and objective medical journals have become both caricatures of their former selves and tools of a political agenda, the editors of the New England Journal of Medicine has weighed in with a non-peer reviewed and unscientific piece of second guessing about an article Merck researchers submitted regarding the VIGOR (Vioxx Gastrointestinal Outcomes Research Study). The editorial, written in a near breathless fashion makes a big deal about three heart attacks associated with Vioxx that were omitted from the study which itself was designed to see if Vioxx was better for the tummy than Aleve. Merck says the heart attacks came after the study occurred, should not have been included and were therefore deleted. The NEJM editors who never explain how they came upon the missing data (it was just discovered, ya see, one night by accident) but you would think that that given the front-page coverage afforded this discovery that the editors had discovered that John Lennon is really alive.
In fact, it is hard to see if the charts cooked up by Drazen and company actual overestimate the relative risk of a heart attack since we do not know (though the FDA does) the actual source, cause and timing of the incident nor whether even at the relative risk they assigned it would have caused the FDA any greater concern about Vioxx labeling than it had expressed at the time. Indeed, the FDA had plenty of data from Merck and other sources about the cardiovascular risk associated with Vioxx, particularly among seniors with rheumatoid arthritis. The question was, and is, at what point and at what dose was it problematic? But the same question can be raised about ANY painkiller. The deletion of three cases was statistical small potatoes back then. It did not stifle concerns. On the contrary, the complex issues about the relative risks and benefits of COX-2 drugs are now being sorted out at a molecular level.
I am not sympathetic to a company that aggressively markets a product beyond what prudent science suggests. But to suggest that Merck deliberately hid data or even imply it in a once reputable medical journal is another form of aggressive marketing and self-promotion that endangers lives as well. Too many people are now not taking important medicines for pain, depression and other illnesses because the NEJM, JAMA, The Lancet and the British Medical Journal have allowed their political love fest with the leftists in the media and their hatred of drug companies to pollute their ability to remain objective. These publications and their editors fancy themselves as rebels with a cause, as insurgents who will stand up against the pharmaceutical industry with hit and run editorials, after the fact articles like Topol and Nissen’s second guessing of the FDA’s review of a diabetes drug and half baked ideas for FDA reform, all the while ignoring more substantive and transformative scientific research that will truly make medicines safer and more effective. Their agenda driven publications are steadily losing credibility. There are many in the scientific community who are fed up with their tyranny and arrogance as well as the damage they are inflicting upon patients.