A controversy is brewing after a document claimed that two major pharmaceutical companies may have misled a medical journal by leaving out some critical data on their drug.
The drug in question is Xarelto, a blood thinner used to treat and prevent blood clots approved in 2011. In 2015, Xarelto made about $1.8 billion in US sales. But it’s also the subject of more than 5,000 lawsuits, 500 of which involve patient deaths.
The New York Times’ Katie Thomas found in a footnote in a federal legal briefing that there might be some evidence that the drug’s developers, Johnson & Johnson and Bayer, may have left out some critical data when a peer reviewer (a researcher who is independent of the study who goes through and vets the findings) at the New England Journal of Medicine asked for it. Peer reviewers are responsible for evaluating the design and data that comes out of studies, to make sure that what the study concludes is accurate. That data could have given the reviewer an idea of how the blood readings from one device compare to another.
This complication comes after months of concern about the design of a trial to test how safe and effective Xarelto was. The goal was to figure out if Xarelto worked better than Warfarin, an older blood thinning drug that has been associated with some serious complications. But the study, it was later revealed, used a blood-testing device that had been recalled.
The study has been contentious, especially with regard to its ties to the recently-approved FDA boss Dr. Robert Califf, who led the trial. Califf has been critiqued because of his connections to the drug industry, which he is now in charge of regulating. And late last month, researchers from Duke University, which led the original study, took another look at their work and concluded that the recalled device didn’t impact the study’s results anyway.
Still, even if the results would not have changed as a result of the comparative data that was reportedly left out, that doesn’t mean leaving them out in the first place wouldn’t be a problem. As Thomas writes:
“But the claim — that industry influence led to the concealing of data — carries echoes, some experts said, of an earlier era of drug marketing, when crucial clinical data went missing from journal articles, leading to high-profile corrections and a wave of ethics policies to limit the influence of drug companies on medical literature.”