Official US documents have revealed that it is possible that the research that took place on an anti-stroke drug included “false data, while its dangerous and deadly side effects were kept secret”.
In 2009, the British medical journal The Lancet published a study of the blood-thinning drug rivaroxaban, which appeared to be “safe and effective”, but the journal has now warned of “inaccuracies” in the study data, pointing out that he “will investigate the research thoroughly. “Greater”.
What is this medicine?
Rivaroxaban, often sold under the brand name Xarelto, is used to prevent strokes and blockage of blood vessels, usually caused by blood clots.
The drug got the green light from international health watchdogs in 2011, and now it’s taken by millions of people around the world every year.
If the claims against the first rivaroxaban study, known as Record4, are correct, patients may have been ‘misled about their potential for side effects’, which include a ‘risk of serious and life-threatening bleeding’ .
This study assessed the drug’s role in preventing blood clots after surgery and has since been cited thousands of times by other researchers as evidence of its safety.
Peter Wilmshurst, a cardiologist at Britain’s Royal Stoke University Hospital who is also active in research fraud campaigns, said: “If serious side effects are more common than officially reported, then the risk is higher. than patients think. Without reliable data, patients say, “I don’t know. Doctors know exactly how safe this drug is.”
He noted that “after warnings about rivaroxaban in other medical reports over the past 10 years, The Lancet has had ample time to issue corrections or remove copies,” according to the British Daily Mail.
The same year that The Lancet published the results of the Record4 trial, the United States Food and Drug Administration (FDA) drug approval body rejected the study.
He concluded that “the data used… are not reliable”. Two years later, following 3 follow-up studies by a different research group, rivaroxaban was approved in the US and UK for stroke prevention.
Controversial experiment
In 2015, a US medical journal analyzed 57 FDA reports of research misconduct, including the controversial rivaroxaban trial, saying the latter involved “falsification, loss of records, and improper storage of medications”.
The Lancet issued its warning after pressure from rival newspaper The British Medical Journal, which in December presented evidence from US Food and Drug Administration reports alleging “serious and multiple data flaws” in the results of 8 of the 16 hospitals that participated in the trial. Rivaroxaban experience.
According to the British Medical Journal, “2 out of 16 hospitals reported no serious side effects, and 4 of the patients who took rivaroxaban in the trial died, which the researchers did not take into account” .
In this regard, Wilmshurst said: “It is appalling that death remains unexplained when a patient dies during a 3 week trial.”
Author’s response
In response to these claims, the trial’s lead author, Emeritus Professor of Medicine at McMaster University in Ontario, Alexander Turby, told the British Medical Journal:
“The Food and Drug Administration is not the arbiter of reliable or unreliable data.”
“Many controlled studies are submitted to reviews, discarded as unreliable, and then resubmitted elsewhere where they can eventually be accepted and published.”
“We believe the data from the Record 4 trial falls into this category: unreliable by the FDA, but strong in terms of conclusions about efficacy and safety.”
It should be noted that “Record 4” was partly funded by the German company “Bayer”, which is one of the pharmaceutical companies that developed the drug.
In 2019, the companies were reported to have generated around £5.4 billion in sales from the drug in just one year.
The new claims are the latest in a series of scandals that have rocked drug research. Last summer, it was revealed that a pivotal Alzheimer’s study “may have been rigged”.
Rivaroxaban is part of a family of drugs called new oral anticoagulants (NOACs), and it is commonly prescribed for heart patients at high risk of stroke and those at risk of having a stroke after joint replacement surgery.
Many patients find the drug easier to take than warfarin, which has been the most commonly prescribed blood thinner for over fifty years, but it cannot be taken with other common drugs, and patients must undergo a medical examination every 6 weeks to monitor serious side effects, such as severe uncontrolled bleeding.
With NOACs such as rivaroxaban, these risks are considered lower, meaning there was no need for ongoing medical checks in hospital.
“We’ve been convinced that this drug is a safer option than warfarin, but that’s not necessarily the case,” Wilmshurst said.
Death and Compensation Claims
In the United States, a series of lawsuits have been filed against the pharmaceutical companies behind rivaroxaban, by relatives of patients who allegedly died of fatal bleeding related to the drug.
In 2019 they agreed to a settlement which included a payment of £650million, although the company did not accept liability, and they stood for the integrity of the property.
And here Wilmshurst said: “These drugs have benefits, and I prescribe them a lot, but there’s not enough evidence to prove they’re necessarily better than the alternatives. And it’s hard to draw conclusions. definitive when we cannot trust the trials that were supposed to tell us whether they are safe and effective.
Answers:
The Lancet magazine commented on what happened saying:
“We take cases of scientific misconduct very seriously and follow good practice guidelines as established by the publication’s ethics committee. The journal published a correction to the original article in December 2022.”
When more details about the FDA report came to our attention, we contacted the authors’ organization to request an investigation.
In turn, Bayer said:
“The Lancet is investigating the validity of the study, not the drug itself”.
“The study in question reports a very specific use of rivaroxaban in a specific group of patients to prevent blood clots after surgery. It used a different dose to use the drug for stroke prevention.”
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