What is this drug?
- "rivaroxaban" (Rivaroxaban), often sold under the trade name "xarelto" (Xarelto)، For the prevention of stroke and vascular occlusion, which usually occur due to blood clots.
- The drug got the green light from international health watchdogs in 2011, and now it’s taken every year by millions around the world..
And if the allegations once morest the early study of the"rivaroxaban"Known as the "Record 4" (Record4) are correct, they may be sick "have been misled regarding the possibility of side effects"Which include "risk of occurrence bleeding severe and possibly fatal".
This study evaluated the role of medication in Prevent blood clots After the surgery, it has since been cited thousands of times by other researchers as evidence of its safety.
Peter Wilmshurst, a cardiologist at Royal Stoke University Hospital in Britain, who is also active in research fraud campaigns, said: "If serious side effects are more common than officially reported, the risk is higher than patients think. Without reliable data, patients and doctors don’t know exactly how safe this drug is".
He pointed it out "Following warnings regarding rivaroxaban in other medical reports over the past 10 years, the Journal of… Lancet Plenty of time to issue corrections or withdraw copies"according to a newspaper "Daily Mail" British.
In the same year it was published "Lancet" Experiment results "Record4"The agency refused to approve the drug US Food and Drug Administration (FDA) studying.
I concluded that "The data used is not reliable". Two years later, following 3 follow-up studies by a different research group, rivaroxaban was approved in the United States and the United Kingdom for the prevention of brain attack.
Controversial experience
- In 2015, an American medical journal analyzed 57 FDA reports of research misconduct, including the controversial rivaroxaban trial, saying that the latter involved "Forgery, loss of records and improper storage of drugs".
- "Lancet" She issued her warning following pressure from the rival magazine "The British Medical Journal"، Which, in December, provided evidence from the US Food and Drug Administration reports, which claimed the existence of "Serious and multiple flaws in the data" In the results of 8 of the 16 hospitals that participated in the rivaroxaban trial.
- According to the British Medical Journal, "Two out of 16 hospitals failed to report serious side effects, and four of the patients who took rivaroxaban in the trial died, which the researchers failed to explain.".
- In this regard, Wilmshurst said: "It is horrific that a death is allowed to go unexplained when a patient dies during a 3-week trial".
Author’s response
In response to the allegations, the trial’s lead author, Professor Emeritus of Medicine at McMaster University in Ontario, Alexander Turby, told the Journal: The British Medical Journal:
- "The Food and Drug Administration is not the arbiter of reliable or unreliable data".
- "Too many controlled studies are submitted to journals, rejected as unreliable, and then resubmitted elsewhere where they can eventually be accepted and published.".
- "We think the Record 4 trial data falls into this category: unreliable by the FDA, but sound conclusions regarding efficacy and safety.".
It has been funded "record4" partly by a corporation "Bayer" German, one of the pharmaceutical companies that developed the drug.
And in 2019, it was reported that companies generated an estimated £5.4 billion in sales from the drug in just one year..
The new allegations are the latest in a string of scandals to rock drug research. Last summer it was revealed that a pivotal study of the disease Alzheimer’s "It may have been rigged".
And"rivaroxaban" It is in a family of medicines called Anticoagulants new oral (NOACs ), and is most commonly prescribed for heart patients at high risk of stroke, and those at risk of having a stroke following joint replacement..
Many patients find that the drug is easier to take than warfarin, which is the most commonly prescribed anticoagulant drug for more than 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 bleeding. severe uncontrolled.
With NOACs like "rivaroxaban"These risks were believed to be lower, which meant that there was no need for constant medical check-ups in the hospital.
Wilmshurst explained that "The idea that this drug is a safer option than warfarin has been sold, but this may not necessarily be the case".
Deaths and claims for compensation
- In the United States, a series of lawsuits have been filed once morest pharmaceutical companies The drug behind rivaroxaban, was reported by relatives of patients who allegedly died from a fatal hemorrhage related to the drug.
- In 2019, they agreed to a settlement that included the payment of £650m in damages, although the company did not accept liability, and they stuck to the safety of the property..
- Here is what Wilmshurst said: "These drugs have advantages, and I prescribe them often, but there is not enough evidence to show that they are necessarily better than the alternatives. And it’s hard to draw firm conclusions when we can’t trust the trials that were supposed to tell us whether it’s safe and effective.".
Responses:
The Lancet magazine commented on what happened by saying:
- "We take cases of scientific misconduct very seriously, and follow best practice guidelines as set out by the Publication Ethics Committee. The magazine published a correction to the original article in December 2022".
- "When more details regarding the FDA report were brought to our attention, we contacted the authors’ institution 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 following surgery. I used a different dose of medication to use for prevention brain attack".
“>
In 2009, the British Medical Journal published:The Lancet” A study regarding The drug “Rivaroxaban” The blood thinner, which appeared to be “safe and effective”, but the journal has now warned of “inaccuracies” in the study’s data, stressing that it will “investigate the research further”..
What is this drug?
- “rivaroxaban” (Rivaroxaban), often sold under the trade name “Xarelto” (Xarelto)، For the prevention of stroke and vascular occlusion, which usually occur due to blood clots.
- The drug got the green light from international health watchdogs in 2011, and now it’s taken every year by millions around the world..
And if the allegations once morest the early study of “rivaroxabanknown as Record 4.Record4) are correct, patients may have been “misled regarding their potential for side effects,” which include “the risk of bleeding severe and possibly fatal.
This study evaluated the role of medication in Prevent blood clots After the surgery, it has since been cited thousands of times by other researchers as evidence of its safety.
Peter Wilmshurst, a cardiologist at Royal Stoke University Hospital in Britain, 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 trustworthy data patients don’t know.” Doctors know exactly how safe this drug is.”
He noted, “After warnings regarding rivaroxaban in other medical reports over the past 10 years, the Journal of Medicine had a Lancet Plenty of time to issue corrections or withdraw copies,” according to the British Daily Mail.
In the same year that the “Lancet” published the results of the experiment “Record4The FDA refused to approve the drug US Food and Drug Administration (FDA) studying.
It concluded that “the data used…is not reliable.” Two years later, following 3 follow-up studies by a different research group, rivaroxaban was approved in the United States and the United Kingdom for the prevention of brain attack.
Controversial experience
- In 2015, an American medical journal analyzed 57 FDA reports of research misconduct, including the controversial rivaroxaban trial, saying that the latter involved “falsification, lost records, and improper storage of drugs.”
- The Lancet issues its warning following pressure from rival magazineThe British Medical Journal”، Which, in December, presented evidence from the US Food and Drug Administration’s reports, which alleged “multiple serious data defects” in the results of 8 out of 16 hospitals that participated in the rivaroxaban trial..
- According to the British Medical Journal, “2 out of 16 hospitals failed to report serious side effects, and 4 of the patients who took rivaroxaban in the trial died, which the researchers failed to explain.”.
- In this regard, Wilmshurst said: “It is appalling that death is allowed to go unexplained when a patient dies during a 3-week trial.”
Author’s response
In response to the allegations, the trial’s lead author, Professor Emeritus of Medicine at McMaster University in Ontario, Alexander Turby, told the Journal: The British Medical Journal:
- “The Food and Drug Administration is not the arbiter of reliable or unreliable data.”
- “A lot of controlled studies are submitted to journals, rejected as unreliable, and then resubmitted somewhere else where they can eventually be accepted and published.”
- “We think the Record 4 trial data falls into this category: unreliable by the FDA, but sound conclusions regarding efficacy and safety.”.
It has been fundedrecord4“Partially by a company”BayerGerman, one of the pharmaceutical companies that developed the drug.
And in 2019, it was reported that companies generated an estimated £5.4 billion in sales from the drug in just one year..
The new allegations are the latest in a string of scandals to rock drug research. Last summer it was revealed that a pivotal study of the disease Alzheimer’s “Maybe it was rigged.”
Rivaroxaban is in a family of medicines called Anticoagulants new oral (NOACs ), and is most commonly prescribed for heart patients at high risk of stroke, and those at risk of having a stroke following joint replacement..
Many patients find that the drug is easier to take than warfarin, which is the most commonly prescribed anticoagulant drug for more than 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 bleeding. severe uncontrolled.
With NOACs Like rivaroxaban, these risks are thought to be lower, which means there is no need for ongoing medical check-ups in the hospital..
“We’ve been sold on the idea that this drug is a safer option than warfarin, but that may not necessarily be the case,” Wilmshurst said.“.
Deaths and claims for compensation
- In the United States, a series of lawsuits have been filed once morest pharmaceutical companies The drug behind rivaroxaban, was reported by relatives of patients who allegedly died from a fatal hemorrhage related to the drug.
- In 2019, they agreed to a settlement that included the payment of £650m in damages, although the company did not accept liability, and they stuck to the safety of the property..
- And here Wilmshurst said: “These drugs have advantages, and I prescribe them a lot, but there is not enough evidence to prove that they are necessarily better than the alternatives. And it is difficult to reach firm conclusions when we cannot trust the trials that were supposed to tell us whether they are safe and effective.”.
Responses:
The Lancet magazine commented on what happened by saying:
- “We take cases of scientific misconduct very seriously, and follow best practice guidelines as set out by the Publication Ethics Committee. The journal published a correction to the original article in December 2022.”
- When more details of the FDA report were brought 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 following surgery. I used a different dose to use the drug to prevent blood clots.” brain attack“.
