Research behind a blockbuster anti-stroke drug could have included fake data while its serious and potentially fatal side effects were kept secret, official US documents have revealed.
In 2009, distinguished British medical journal The Lancet published a major study on the blood thinner rivaroxaban, which appeared to show it was safe and effective.But now the journal has warned of ‘inaccuracies’ in the trial data and said that it would be investigating the research further.
Rivaroxaban, often sold under the brand name Xarelto, is approved by health watchdogs NICE for the prevention of stroke and embolisms – blocked blood vessels, usually caused by blood clots.It got the green light from international health watchdogs in 2011, and now each year it is taken by thousands of Britons and millions worldwide.
If the claims against the early rivaroxaban trial – named Record4 – are true, patients may have been misled about the probability they’ll experience side effects, which include the risk of severe and even potentially fatal bleeding.That study assessed the drug’s role in preventing blood clots after surgery, but it has since been cited by other researchers thousands of times as proof of its safety.
Rivaroxaban, often sold under the brand name Xarelto, is approved by health watchdogs NICE for the prevention of stroke and embolisms (stock image)
‘If serious side effects are more common than has been officially reported, the risk is higher than patients have been led to believe,’ says Dr Peter Wilmshurst, a cardiologist based at the Royal Stoke Best Private University Hospital who is also a research fraud campaigner.’Without trustworthy data, patients and doctors don’t know exactly how safe this drug is.’
He added that following warnings about rivaroxaban in other medical reports over the past ten years, The Lancet has had ‘plenty of time’ to issue corrections or retract the paper.