AstraZeneca is facing more allegations concerning data manipulation in its PLATO clinical trial as a doctor files a sealed complaint in the U.S. District Court for the District of Columbia, according to the Wall Street Journal.
The PLATO trial is currently the subject of an ongoing investigation by the U.S. Justice Department following a report in the International Journal of Cardiology which claimed information over a number of adverse event reports and deaths had been left out of submissions made to the U.S. Food and Drug Administration.
The latest filing, however, claims that researchers falsified information concerning Brilinta’s competitor Plavix in order to make Brilinta seem safer and more effective.
In his claim, Dr. Victor Serebruany, an adjunct medical professor at John Hopkins Hospital, contends that the number of deaths in the study’s control group – those who took Plavix – was unusually high compared to previous trials.
An FDA review-team leader who asked Dr. Serebruany to review the data, Thomas Marciniak, cited clnical trial documents indicating that 12 patients had reported their own deaths by telephone.
Additionally, Serebruany disputed the tabulation of heart attacks in the study, claiming that data was manipulated to create a more favorable view of Brilinta.
Serebruany has filed the complaint under the federal False Claims Act, meaning that the U.S. Government has the option to join the lawsuit to recover money as well.
“An estimated 23 definite or possible cardiovascular events or deaths on ticagrelor (Brilinta) were either not submitted for adjudication, inactivated, deleted or were downgraded to ‘softer’ endpoints.” – James DiNicolantonio, Pharm.D., and Dr. Ales Tomek in a report published by the International Journal of Cardiology
The investigation was launched after two health care professionals released a report alleging that important data concerning the risks associated with Brilinta was misrepresented when study results for the PLATO trial were submitted to the FDA for review.
According to the doctors, at least 23 instances of serious adverse events and death were left out of the final results or were mitigated to less severe adverse events.
Beyond those involved in the trial, patients currently taking Brilinta could be at risk. If the drugs was approved due to incorrect data, physicians may be lacking a full understanding of the drug’s risks.