In a follow -up investigation into multimillion -dollar drug ticagrelor, The BMJ He has discovered new concerns, this time in key platelet studies used in its FDA approval.
For more than a decade, Ticagrelor (Brilinta in the United States and Brilique in Europe) has been recommended for patients with acute coronary syndrome, a variety of conditions related to the sudden reduced blood flow to the heart.
Last December, an investigation carried out by the BMJ found serious data integrity problems in the historical clinical trial (dish) that was used to obtain the global approval of Ticagrelor, questioning the advantage of the medicine over the cheapest rivals.
Now, as the generic versions of the medication prepare to launch this year, the BMJ has expanded its research, observing two key platelet studies that Astrazeneca said they explained the ticagrelor’s ability to successfully treat acute coronary syndrome.
He finds that the results of the “primary end point” (the key measurement of the trial) for both clinical trials were informed inaccurate in the main circulation of the Magazine of Cardiology, and reveals that more than 60 of 282 readings of platelet machines used in the trials were not present in the data sets of the Food and Drug Administration (FDA) of the United States.
In addition, an active rehearsal researcher never became a study author, while an author told the BMJ that he was not involved in the trial, and most researchers, including the principal investigator, could not be said or declined to be interviewed.
Victor Serebruany, an attached member of the Faculty of the Johns Hopkins University and the most renowned critic of Ticagrelor, told the BMJ that “there are episodes of rebound shooting and a deep inhibition of platelets after Ticagrelor made the patients of their own to thrombosis or hemorrhages.
The circulation and Astrazeneca did not respond to a request for comments.
Serebruany added: “It has been obvious for years that there is something wrong with the data. That the leadership of the FDA could see beyond all these problems, in addition to the many problems that their own reviewers identified and are now being discovered by the BMJ, it is inconceivable. We all need to know how and why it happened.”
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