BMJ exclusive: Lancet is under pressure to retract “unreliable” paper as investigation drags on
Nineteen months after an investigation was promised into a trial of the anticlotting drug RIVAROXABAN, the journal and the university involved are keeping silent about progress.
My latest piece for The BMJ:
Rivaroxaban, often sold under the brand name XARELTO®, is an anticlotting drug approved to treat venous thromboembolism (VTE) - blood clots that form in the veins.
In the UK, the drug is approved to lower the risk of blood clots developing in patients who have a condition called atrial fibrillation (an abnormal heart beat) as well as other risk factors for stroke.
Rivaroxaban was also suggested as a prophylaxis therapy in COVID-19 patients who’d been discharged from hospital and at high risk of developing blood clots.
The drug, dubbed the “warfarin alternative,” has been prescribed more than 80 million times in the US alone.
In 2020, it was rated 10th in the global sales rankings and generated almost US$7 billion that year.
BACKGROUND:
In 2006, the RECORD4 study was conducted to examine rivaroxaban for the prevention of VTE in patients undergoing elective total knee replacement.
But an inspection audit of the study’s clinical trial sites by the US FDA uncovered numerous and serious data integrity deficiencies at 8 of the 16 sites.
The RECORD4 study was published in the Lancet and made no mention of the data integrity issues. The manufacturer (Janssen) kept it quiet from the public and the trial investigators.
Until, in 2022, I sent the FDA’s audit report to the lead investigator of the RECORD4 study, Alexander Turpie, emeritus professor of medicine at McMaster University, Ontario.
Turpie said he had no knowledge of the data integrity issues and later published a correction in the Lancet, apologising for the errors.
They were “serious” issues including the failure to randomise many of the participants, serious adverse events were under-reported, and there were “unexplained deaths” of some participants during the study period.
When asked if the Lancet would retract the article in light of the FDA’s audit report which rendered the study “unreliable,” the journal said it would consider the possibility and open an investigation, which I reported in The BMJ in December 2022.
It has been 19 months since an investigation was promised, but the Lancet and McMaster University, are keeping silent about its progress.
Click on the icon for the full story - apologies to those without access to The BMJ as it is behind a paywall.
For PAID SUBSCRIBERS, here are some extended comments by Peter Wilmshurst, honorary consultant cardiologist and campaigner against medical misconduct.
