Trust the experts and Big Pharma. The nothing can be done crowd are upset that Kennedy has trashed the FDA drug oversight committee for not actually being a drug oversight committee but a rubber stamp. Hidden trial results no problem. Adverse Events not used to challenge the drug. Critics ignored. The CDC should have as a priority of fixing the VAERS data base to turn it into an actual useful tool that actually gets used.
Scientists Uncover New Concerns About Billion-Dollar Heart Drug
By BMJ GroupJune 29, 2025
New findings suggest serious data issues behind a major heart drug’s approval, reigniting concern over its decade-long use. Credit: Stock
An investigation has uncovered evidence of significant misreporting, raising new concerns about the approval and long-term use of ticagrelor over the past decade.
In a follow-up investigation into the multibillion-dollar drug ticagrelor, The BMJ has identified new concerns, this time focusing on key platelet studies that supported the drug’s approval by the FDA.
For over ten years, ticagrelor (sold as Brilinta in the US and Brilique in Europe) has been recommended for patients with acute coronary syndrome, a group of conditions involving a sudden reduction in blood flow to the heart.
In December, The BMJ reported serious issues with data integrity in the landmark PLATO clinical trial, which played a central role in ticagrelor’s global approval. The findings raised doubts about the drug’s claimed benefits over less expensive alternatives.
Concerns resurface as generics enter the market
Now, with generic versions of the drug expected to launch this year, The BMJ has broadened its investigation to examine two key platelet studies that AstraZeneca cited as evidence of ticagrelor’s effectiveness in treating acute coronary syndrome.
It finds that the “primary endpoint” results (the trial’s key measurement) for both clinical trials were inaccurately reported in the leading cardiology journal Circulation, and reveals that more than 60 of 282 readings from platelet machines used in the trials were not present in US Food and Drug Administration (FDA) datasets.
What’s more, one active trial investigator never became a study author, while one author told The BMJ he was not involved in the trial, and most investigators, including the principal investigator, were unreachable or declined to be interviewed.
Expert criticism and lack of transparency
Victor Serebruany, an adjunct faculty member at Johns Hopkins University and ticagrelor’s most renowned critic, told The BMJ that “there are episodes of skyrocketing rebound and profound platelet inhibition after ticagrelor making patients prone to thrombosis or bleeding. If doctors had known what happened in these trials, they would never have started using ticagrelor.”
Circulation and AstraZeneca did not respond to a request for comment.
Comments
Trust the experts and Big Pharma. The nothing can be done crowd are upset that Kennedy has trashed the FDA drug oversight committee for not actually being a drug oversight committee but a rubber stamp. Hidden trial results no problem. Adverse Events not used to challenge the drug. Critics ignored. The CDC should have as a priority of fixing the VAERS data base to turn it into an actual useful tool that actually gets used.
https://scitechdaily.com/scientists-uncover-new-concerns-about-billion-dollar-heart-drug/
Scientists Uncover New Concerns About Billion-Dollar Heart DrugBy BMJ GroupJune 29, 2025
New findings suggest serious data issues behind a major heart drug’s approval, reigniting concern over its decade-long use. Credit: Stock
An investigation has uncovered evidence of significant misreporting, raising new concerns about the approval and long-term use of ticagrelor over the past decade.
In a follow-up investigation into the multibillion-dollar drug ticagrelor, The BMJ has identified new concerns, this time focusing on key platelet studies that supported the drug’s approval by the FDA.
For over ten years, ticagrelor (sold as Brilinta in the US and Brilique in Europe) has been recommended for patients with acute coronary syndrome, a group of conditions involving a sudden reduction in blood flow to the heart.
In December, The BMJ reported serious issues with data integrity in the landmark PLATO clinical trial, which played a central role in ticagrelor’s global approval. The findings raised doubts about the drug’s claimed benefits over less expensive alternatives.
Concerns resurface as generics enter the market
Now, with generic versions of the drug expected to launch this year, The BMJ has broadened its investigation to examine two key platelet studies that AstraZeneca cited as evidence of ticagrelor’s effectiveness in treating acute coronary syndrome.
It finds that the “primary endpoint” results (the trial’s key measurement) for both clinical trials were inaccurately reported in the leading cardiology journal Circulation, and reveals that more than 60 of 282 readings from platelet machines used in the trials were not present in US Food and Drug Administration (FDA) datasets.
What’s more, one active trial investigator never became a study author, while one author told The BMJ he was not involved in the trial, and most investigators, including the principal investigator, were unreachable or declined to be interviewed.
Expert criticism and lack of transparency
Victor Serebruany, an adjunct faculty member at Johns Hopkins University and ticagrelor’s most renowned critic, told The BMJ that “there are episodes of skyrocketing rebound and profound platelet inhibition after ticagrelor making patients prone to thrombosis or bleeding. If doctors had known what happened in these trials, they would never have started using ticagrelor.”
Circulation and AstraZeneca did not respond to a request for comment.