An investigation by the British Medical Journal has concluded that Janssen, the pharmaceutical arm of Johnson and Johnson, had concerns about an allegedly faulty device in a regulatory trial.
The BMJ also suggests that the drug manufacturer did not share data about the blood testing device with the Food and Drug Administration (FDA) before the clinical trial approval process.
Drug trial lawyer Gene Matthews stated that this incident “emphasised the need for drug manufacturers to be completely transparent about any potential health risks that clinical trial participants may face”.
The device that caused problems in the clinical trial was the blood testing INRatio device, which was used in the phase III trial (ROCKET AF) of the anticoagulant rivaroxaban.
Soon after the trial a safety programme (the Covance recheck programme) was set up because of concerns about the accuracy and reliability of the device that was being used to monitor patients receiving warfarin. The BMJ say that Janssen failed to share this data with the safety monitoring board of the trial.
Rivaroxaban (Xarelto) is marketed outside the US by Bayer who, the BMJ say, were also aware of concerns about the device.
The trial results were published in the New England Journal of Medicine in 2011 and concluded that rivaroxaban was “similar to warfarin in its ability to prevent” ischaemic stroke or systemic embolism in people with non-valvular atrial fibrillation.
The device under scrutiny, INRation, was recalled by the FDA in December 2014 because INR results it generated could be “clinically significantly lower” than those found by a laboratory method.
The BMJ investigation reveals that Janssen and Bayer did not tell regulatory authorities that the device used in the trial had been recalled, potentially compromising the safety of participants.
Gene Matthews of the product liability team at Leigh Day added:
“Any potential problems with equipment or devices used during clinical trials should immediately be reported to the appropriate regulatory authorities.
“Clinical trials are closely regulated for a reason – to protect the safety of participants. If the devices being used in this trial were producing incorrect data this could have compromised the safety of participants.”