Millions of people may be at risks of strokes and heart attacks because they’re being prescribed a drug that doesn’t work.
Doctors have raised serious concerns about the efficacy of AstraZeneca’s Brilinta, which is given to people with a history of heart attack or blood vessel conditions that put them at risk of deadly clots, strokes and heart attacks.
The drug, known scientifically as ticagrelor, was approved by the FDA in 2011 despite widespread pushback from scientists over concerns about its trial results.
Since then, a number of studies have suggested that though ticagrelor is better than doing nothing, it is not as good as competitors at preventing massive bleeding, strokes and death from blood clots.
Estimates suggest that as many as 2million people could be on the drug – and the US government spent over $750million on the drug through Medicare and Medicaid.
Dr Victor Serebruany, at Johns Hopkins University, who has been critical of the drug for at least a decade said that the Department of Justice should look into ticagrelor.
Dr Serebruany said the DOJ should: ‘issue new civil investigative demands, and stop the flirting, dealing, and wheeling in exchange for future high profile jobs in big pharma. Then the American people will receive justice.’
These critics are combined with other scientists in a new report, which calls for a re-examining of ticagrelor.
Game Of Thrones star Emilia Clarke shocked fans when she revealed how she thought she was going to die when she had an aneurysm in 2011 which led to a stroke. An aneurysm occurs when the blood vessels of the brain weaken and stretch, which can make them more likely to burst
Ticagrelor is said to reduce the blood’s natural tendency to clot, in turn reducing the number of life-threatening blood clots that may lead to brain bleeds and heart disease. The body naturally forms blood clots in order to patch wounds and stop bleeding.
But over time, things like age, smoking and excessive weight gain can make blood clots more common. These kinds of clots also become more common after someone has a heart attack or blood vessel disorder, coronary artery disease.
When someone overproduces these clots they can clog blood vessels, interrupting blood flow or weakening the walls of blood vessels, causing aneurysms which lead to massive brain bleeds.
So when someone comes to the doctor after a previous heart or blood vessel condition, the doctor might prescribe them a drug like ticagrelor.
Without insurance, one bottle of 60 tablets of Brilinta a may cost about $450.
It’s commonly taken for between six months to a year after a heart attack, twice a day at either 90 mg or 60 mg, alongside aspirin.
The report was published in the British Medical Journal by it’s senior editor, DrPeter Doshi, a professor at University of Maryland School of Pharmacy.
Dr Doshi looked back at the original trial which approved the drug, which took place in 2009. It included more than 18,000 people from 43 countries.
Brilinta’s first application for approval was not accepted in 2009. On second try in 2011, the drug was approved
In order for ticagrelor to get approved, clinical trials had to prove that it was a better drug than competitors, like clopidogrel and prasugrel, in a phase 3 trial.
After phase 3, the drug gets approved to be put on the market, but the FDA continues monitoring it in phase 4 trials, to see if there are any additional problems with the drug.
According to Dr Doshi the results from the phase 3 trial found that American patients suggested that those who took ticagrelor were at 27 percent higher risk of bad outcomes like stroke, severe bleeding, heart attack and death than people who took similar drugs.
The FDA then didn’t approve the drug, though other countries did at the time.
AstraZeneca reapplied for approval in 2010, saying that the results from the American trials had to do with differences in aspirin dosing.
Thomas Marciniak, an FDA medical officer who reviewed this second application, said it was ‘the worst in my experience regarding completeness of the submissions and the sponsor responding completely and accurately to requests.’
The star had a second brain bleed in 2013, which needed surgery. It’s unclear if Clarke was also put on blood thinners or anticoagulants, like the drug investigated by the new report
Marciniak recommended against approving it. Still, in 2011, the FDA granted Astrazenca approval for ticagrelor.
According to Dr Doshi, the past 13 years of monitoring shows that the drug isn’t as effective as alternatives.
A 2015 study in Japan found that people 9 percent of people on ticagrelor experienced severe bleeding, stroke or death versus 6.3 percent of people on similar drugs.
Eric Bates, a professor of internal medicine at University of Michigan, had originally recommended the drug, but changed his tune once he saw trials like these.
He said: ‘Every time one of those negative trials came out, the news magazines would quote one of the investigators—who had an intellectual [and] financial bias—discounting it. And I said, “Wait a second, let’s just add up the skeletons here.”‘
Dr Doshi said that scientists like Dr Serebruany recommend the Department of Justice get involved.
The department initiated a 2013 probe into the drug and its trials, but halted it a year later, saying: ‘After an extensive investigation . . . we determined that the allegations lacked sufficient merit such that it was not in the best interests of the US to intervene in the suit.’
Dr Serebruany said: ‘we need to give them another chance to look at the case.;
AstraZeneca declined to be interviewed for Dr Doshi’s new report.
