Multibilian dollars in a follow -up investigation in drug Tikgralor, BMJ Fresh concerns have been exposed, this time in major platelet studies used in its FDA approval.

For more than a decade, Ticagrelor (Brillinta in the US and brillic in Europe) have been recommended for patients with acute coronary syndrome – a series of conditions related to sudden low blood flow in the heart.

Last December, a BMJ investigation found serious data integrity problems in the Landmark Clinical Trial (Plato), used to obtain approval worldwide for Ticagrelor, questioning the benefits of the drug on cheap rivals.

Now, as the general versions of the drug are ready to launch this year, BMJ has expanded its investigation, with two major platelet studies, that Astrazheneka claimed that the ability to successfully treat Tikgralor’s acute coronary syndrome was explained.

It finds that the “primary closing point” result (major measurement of the test) for both clinical trials was incorrectly reported in the leading cardiology journal circulation, and it suggests that more than 60 of the 282 reading US Food and Drug Administration (FDA) from platelet machines used in the tests were not present in the dataset.

What is more, an active testing explorer never became a study writer, while a writer told the BMJ that he was not involved in the test, and most investigators, including the leading investigator, were unattainable or refused to interview.

Victor Cerebrony, an assistant faculty member at the University of Johns Hopkins, and the most famous critic of Tikagralore, told the BMJ that “Tikgraler is an episode of the sky -touching ribounds and intensive platelet prohibition after thrombosis or bleeding. If the doctors had not started this test, what did they ever do.”

Circulation and Astrajeneka did not respond to the remarks request.

It is clear over the years that there is something wrong with the data. The leadership of the FDA can see all these problems-at the top of all the problems that have been identified by their own critics and are now being discovered by BMJ-IS unconscious. We all need to know how and why it happened. ,

Victor Cerebruney, Assistant Faculty Member, Johns Hopkins University