If you have Afib, chances are your doctor has you taking a blood thinner.
He no doubt told you how having this kind of abnormal heart rhythm can up your odds of a stroke.
But there are some things you probably didn’t hear — especially the back-room secrets about one of the most popular blood thinning drugs out there.
And that’s not all.
Researchers are now saying that not everyone with Afib needs one of these risky blood-thinning meds in the first place.
In the last week of September the British Medical Journal dropped a bombshell investigation that uncovered some classic Big Pharma-style deception. (We can only guess at how often this stuff happens behind the scenes without anyone hearing about it.)
Here’s what the BMJ uncovered.
Janssen, the pharmaceutical division of Johnson & Johnson, developed the blood-thinner Xarelto with Bayer a few years ago. It then launched a major trial called Rocket-AF to get the drug approved.
But there was just one little problem.
They used a device called INRatio to test blood samples and prove that Xarelto was doing its job. And guess what? That INRatio device was so defective that it has since been recalled!
So what did Janssen executives do when they figured out that this device was spewing out junk test results?
According to the BMJ, Janssen “withheld data from the Food and Drug Administration” about the faulty device.
That shady little move was bad news in two ways. One: The Rocket trial continued even though Afib patients who volunteered may have been at risk. And two: Xarelto was approved by the FDA based on flawed trial results.
But it gets worse.
Just a few days after BMJ exposé, JAMA Internal Medicine published a study that showed Xarelto to be much more dangerous when it comes to the risk of a deadly bleed — both in the brain and GI tract — than a competing anticoagulant drug.
So now we know that Xarelto is not only an incredibly risky med, but one that was approved based on defective test data.
And what did the FDA do about that?
The agency said in a recent statement that after applying a “variety of analyses” it somehow was able to figure out that the Rocket trial was just fine. No penalty for Janssen or redo necessary!
So why bother having a safety trial at all?
But in the midst of all these shady maneuvers, there is some good news for Afib patients.
Two studies, one just out, found that having Afib doesn’t automatically mean you have to start up on one of these risky drugs.
Last year, a big study out of the University of California discovered that around a quarter of Afib patients, ones at low risk for a stroke, have no business being on them at all.
The researchers said that the very fact so many low-risk Afib patients were being given blood thinners should be a “wake-up call” for doctors.
And in the most recent issue of the journal Circulation, researchers found that patients who only have “short bouts” of Afib also shouldn’t be taking a blood thinner.
If you’re currently being prescribed one of these meds for Afib, whether it’s Xarelto or any other brand, make an appointment to see your doctor as soon as possible. Ask him about this research and if you are in that low-risk or short-burst group and can stop taking the drug.
Because as thousands of Afib patients who have filed lawsuits over harms from Xarelto (and other blood-thinning meds) already know, this is one ounce of prevention that comes with a pound of risk.
“FDA clears Xarelto blood thinner despite faulty trial device” Reuters, October 11, 2016, Fox News, foxnews.com