Turns out, one of the world’s best-selling drugs was approved as the result of a botched study.
Its research was screwed up so badly that it’s now almost impossible to say for sure if this thing is safe.
The FDA found out… but instead of ordering a halt to all sales and demanding a new study, last week the agency announced there’s nothing to worry about and the blood thinner rivaroxaban, a.k.a. Xarelto, can stay on the market anyway.
WHAT?! This wasn’t some minor or meaningless issue with the study — this was a MONUMENTAL disaster, and one that disqualifies EVERYTHING in the study.
Meanwhile, folks who took this drug are already realizing they made a huge mistake. There are now some 11,000 federal lawsuits against this drug, with more likely being added every day.
In the study, rivaroxaban was put up against the “old standard” blood thinner, warfarin. If you’ve ever taken warfarin yourself — or you’re on it right now — you know docs need to keep careful track of your levels so your blood doesn’t get TOO thin.
In the study, those levels were tracked with a device that was spitting out false readings, making the warfarin seem more dangerous than it already is (and believe you me, it’s already plenty dangerous).
Those false alarms made the warfarin look riskier — which, in turn, made the rivaroxaban seem safer by comparison.
But is it really?
We might never know, because the FDA had the nerve to claim this faulty device had “minimal” impact on the study.
That flies in the face of the agency’s own warning. They actually recalled that device, saying that using it can “cause severe or life-threatening injuries, including death.”
And it flies in the face of the alleged actions by the company behind the drug, Johnson & Johnson’s Janssen Pharmaceuticals — who are accused of doing their best to hush this up so they can keep raking in billions off their new blockbuster drug rather than face the music from the feds.
They shouldn’t have worried; their old pals at the FDA clearly weren’t going to let them down. The fix was in all along.
If you’re at an increased risk of stroke due to a dangerous condition like atrial fibrillation… and therefore need to take a blood thinner… do yourself a favor. See a doc who’ll give you ALL your options, and not just the ones the drug industry is pushing.
For that, I recommend working closely with an experienced member of the American College for Advancement in Medicine.