Millions of people may be at risk of strokes and heart attacks because they are prescribed a drug that doesn’t work.
Doctors have raised serious concerns about the effectiveness of AstraZeneca’s Brilinta, which is given to people with a history of heart attack or blood vessel disease that puts them at risk of fatal clots, strokes and heart attacks.
The drug, scientifically known as ticagrelor, was approved by the FDA in 2011 despite widespread resistance from scientists over concerns about the study results.
Since then, a number of studies have suggested that while ticagrelor is better than doing nothing, it is not as good as competitors at preventing massive bleeding, stroke and death from blood clots.
Estimates suggest that as many as 2 million people could be using the drug – and the US government has spent more than $750 million on the drug through Medicare and Medicaid.
Dr. Victor Serebruany of Johns Hopkins University, who has been critical of the drug for at least a decade, said the Justice Department should investigate ticagrelor.
Dr. Serebruany said the DOJ should: “issue new civil investigative demands, and stop the flirting, dealing and fiddling in exchange for future high-profile jobs in big pharma.” Then the American people will get justice.”
These critics are combined with other scientists in a new report calling for a reexamination of ticagrelor.
Game Of Thrones star Emilia Clarke shocked fans when she revealed how she thought she was going to die when she suffered an aneurysm that led to a stroke in 2011. An aneurysm occurs when the brain’s blood vessels weaken and stretch, making them more likely to burst
Ticagrelor is said to reduce the blood’s natural tendency to clot, reducing the number of life-threatening blood clots that can lead to brain hemorrhages and heart disease. The body naturally forms blood clots to repair wounds and stop bleeding.
But over time, things like age, smoking, and excessive weight gain can make blood clots more common. These types of clots are also more likely to occur after someone has had a heart attack or a blood vessel condition called coronary artery disease.
When someone overproduces these clots, they can clog blood vessels, interrupt blood flow, or weaken blood vessel walls, causing aneurysms that lead to massive brain hemorrhages.
So if someone comes to the doctor after a previous heart or blood vessel condition, the doctor may prescribe him or her a drug such as ticagrelor.
Without insurance, a bottle of 60 Brilinta tablets can cost about $450.
It is usually taken six months to a year after a heart attack, twice a day at a dose of 90 mg or 60 mg, in addition to aspirin.
The report was published in the British medical journal by editor-in-chief, DrPeter Doshi, a professor at the University of Maryland School of Pharmacy.
Doctor Doshi looked back to the original drug approval process, which took place in 2009. It involved more than 18,000 people from 43 countries.
Brilinta’s first application for approval was not accepted in 2009. The drug was approved on the second attempt in 2011
To get ticagrelor approved, clinical trials had to prove in a phase 3 trial that it was a better drug than competitors such as clopidogrel and prasugrel.
After Phase 3, the drug is approved for market, but the FDA continues to monitor it in Phase 4 trials to see if there are any more problems with the drug.
According to Dr. Doshi found the results of the Phase 3 trial suggested that American patients found that those taking ticagrelor had a 27 percent higher risk of bad outcomes such as stroke, major bleeding, heart attack and death than people taking similar drugs.
The FDA subsequently did not approve the drug, while other countries did at the time.
AstraZeneca reapplied for approval in 2010, saying the results of the U.S. trials were related to differences in aspirin dosing.
Thomas Marciniak, an FDA medical officer who reviewed this second application, said this was “the worst in my experience in terms of the completeness of the submissions and the sponsor’s complete and accurate response to requests.”
The star suffered a second brain hemorrhage in 2013, which required surgery. It is unclear whether Clarke was also given blood thinners or anticoagulants, such as the drug examined in the new report
Marciniak recommended not approving it. Still, in 2011, the FDA granted Astrazenca approval over ticagrelor.
According to Dr. Doshi, the past thirteen years show that the drug is not as effective as alternatives.
A 2015 study in Japan found that 9 percent of people taking ticagrelor experienced major bleeding, stroke or death, compared with 6.3 percent of people taking similar drugs.
Eric Bates, a professor of internal medicine at the University of Michigan, had initially recommended the drug but changed his tune when he saw such studies.
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 – and downplay it. And I said, ‘Wait a minute, let’s add up the skeletons here.'”
Dr. Doshi said scientists like Dr. Serebruany recommend that the Department of Justice get involved.
The department launched an investigation into the drug and its trials in 2013, but stopped it a year later, saying: ‘After an extensive investigation. . . we determined that the allegations were not sufficiently substantiated such that it was not in the best interests of the U.S. to intervene in the lawsuit.”
Dr. Serebruany said: ‘we should give them another chance to look into the matter.;
AstraZeneca declined to be interviewed for Dr.’s new report. Doshi.