Millions of patients at high risk of a fatal heart attack could be taking a drug that may not even be effective, top doctors have warned.
Anti-clotting pill ticagrelor was approved for use on the NHS in 2011 after trials claimed it could prevent one in five deaths after a heart attack.
The twice-daily pill, sold as Brilinta, is given to people with acute coronary syndrome —a sudden reduction of blood to the heart—reducing the risk of deadly clots and strokes.
Now, experts have discovered 'evidence of serious misreporting' in two clinical trials, pivotal to getting the drug approved in the UK and US, 'raising doubts over its approval'.
The BMJ investigation claimed the 'primary endpoint' results—the key measure to determine whether a treatment is effective—for both trials were inaccurately reported in leading cardiology journal Circulation.
It also said around a quarter of the readings from machines used in the trials were not included in the data sets, the US medicine's regulator, the Food and Drug Administration (FDA) used to approve the drug.
Dr Victor Serebruany, an expert in cardiovascular pharmacology at Johns Hopkins University in Maryland, who has been critical of the drug for over a decade said: 'It's been obvious for years that there is something wrong with the data.
"That the FDA's leadership could look past all these problems—on top of the many problems their own reviewers identified and are now being discovered by The BMJ—is unconscionable.
"We all need to know how and why that happened.
"If doctors had known what happened in these trials, they would never have started using ticagrelor."
Source: Mail Online, 20 June 2025
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