‘Unsafe’ heart drug may be a killer

Heart patients have been harmed—and some even killed—by a revolutionary drug whose safety trials have been thrown into question.

The drug comes out of patent this year, which means that many more versions will be launched, putting even more heart patients at risk.

For more than a decade, AstraZeneca’s ticagrelor (Brilinta in the US and Brilique in Europe) has been the drug of choice for doctors treating people with acute coronary syndrome, a range of conditions related to reduced blood flow to the heart.

It generates more than $1 bn in sales every year—but data about its safety and effectiveness may have been falsified, say researchers from the BMJ, the medical journal.

Last December, an investigation by the BMJ found serious data issues in the landmark PLATO clinical trial that was used to gain worldwide approval, and now investigators have looked at two key platelet studies that AstraZeneca claimed explained ticagrelor’s ability to treat acute coronary syndrome successfully.

It finds that the positive results for both clinical trials were inaccurately reported in the leading cardiology journal Circulation, and more than 60 of 282 readings from platelet machines used in the trials were not handed over to the US’s drug regulator, the Food and Drug Administration (FDA), during the approval process.

Furthermore, one active trial investigator never became a study author—suggesting he may have had misgivings about the trial process—while one author said he was not even involved in the trial.  Most investigators, including the principal investigator, declined to be interviewed.

Victor Serebruany, an adjunct faculty member at Johns Hopkins University and ticagrelor’s most vocal critic, told the BMJ that the drug increased the risk of thrombosis or bleeding. “If doctors had known what happened in these trials, they would never have started using ticagrelor,” he said.

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