The Vioxx Mistrial
This article is from the archive of The New York Sun before the launch of its new website in 2022. The Sun has neither altered nor updated such articles but will seek to correct any errors, mis-categorizations or other problems introduced during transfer.

Yesterday’s mistrial in the third Vioxx lawsuit to go to a jury suggests that last week’s “new” disclosures about supposedly faulty data in one study of the drug could be hitting a jury before you know it. Plaintiffs’ attorneys must be relieved at the thought of a second shot in the case at hand with more “damning” evidence after failing to convince all but one juror the first time around. But before anyone gets too excited, let’s review what we do and don’t know about the New England Journal of Medicine study that has the tort bar drooling and New York Times editorialists hyperventilating.
We do know that the study found a somewhat higher risk of heart attack from taking Vioxx as compared to naproxen, the active ingredient in over-the-counter Aleve. We know a paper about the drugs’ effects on patients’ stomachs noted the difference in heart risk. We know that some data quantifying Vioxx risks more precisely were not included in that paper. In other words, not to put too fine a point on it, we don’t know anything now that we didn’t know four and a half years ago.
The research in question was funded by Merck, conducted by 12 researchers, and published in the Journal’s November 23, 2000, issue under the eye-catching headline “Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis.” As that title suggests, the researchers were actually on the lookout for ulcers. They did notice, however, a higher number of Vioxx patients suffering heart ailments, a result they duly reported in the paper. Three patients in the study suffered heart attacks – of the non-fatal variety – after the cutoff date the researchers had previously set when designing an experiment that wasn’t even investigating heart attacks. The data were included in an original draft of the paper. While it isn’t entirely clear why they were deleted, doing so was certainly consistent with standard scientific practice. And those heart attacks were reported in data supplied to the Food and Drug Administration and then publicly released within three months of the publication of the Journal article.
Plaintiffs’ lawyers, and even some editorialists like those at the New York Times, have spent the past few days trying to spin this as an example of Merck manipulating data in a self-funded study that was used to market the drug. They will have to navigate, however, the inconvenient fact, reported by the Wall Street Journal over the weekend, that when Merck sent out the New England Journal article in its marketing materials, it included a four-page summary noting the existence of the three disputed heart attacks and recalculating the cardiac risk accordingly. The researchers’ most serious “crime” here appears to be that they strictly adhered to basic scientific methods governing how to design studies of this type.
To be sure, unanswered questions about this incident remain. For example, why didn’t the New England Journal’s editors speak up in February 2001, when data on the three heart attacks were first released as part of an FDA report? Why didn’t they say anything in October 2004, when Vioxx was pulled from the market and the editors claim they first re-read this study? Why have they waited a month after an editor claims he was first made aware in a deposition of the researchers’ decision to delete the data from an earlier version of the study? Why did they finally decide to publish an editorial on the matter just as a federal jury was deliberating in a high profile Vioxx trial?
None of these questions, however, has to do with Merck. And none of the data at issue have much bearing on the federal case that hung a jury yesterday. Richard Irvin Jr. took Vioxx for less than a month before suffering a fatal heart attack; to the extent that the medicine posed an increased risk, it was only for patients who used it for a longer span. Eight of the nine federal jurors appear to have understood this, which may be why the chance to portray Merck as a big, bad corporate wolf that the New England Journal has so conveniently provided came as such a relief to trial lawyers.
What we’re left with as a result of this tempest in a pill bottle is the startling “revelation” that researchers funded by Merck designed a drug trial according to accepted scientific practices and reported the data appropriately; they didn’t conceal adverse data from the government or from doctors, but just reported those data in a more appropriate forum. Whatever else this episode might say about the state of modern medical publishing, it’s hard to see any warning about company-funded drug research here. Even more broadly, it says that this whole Vioxx controversy is primarily about the greed of the tort bar and about the hostility to capitalism in parts of the press.