No more blood tests!
That whopper of a selling point has been used to pedal the blood-thinner Pradaxa (dabigatran) since it hit the market in 2010. And boy has it worked.
At least 850,000 prescriptions have been written for the drug since Big Pharma giant Boehringer Ingelheim first introduced us to their 30-billion-dollar baby.
Despite its $300 bucks a month price tag, Pradaxa has sold like hotcakes, and if you… or someone you care about… has ever been on the old standby drug Coumadin (warfarin) it’s not hard to understand why.
Coumadin users… who spend about $4 a month on their drug… are forced to make frequent trips to see their doctor, or a lab tech, to get their blood levels monitored. It’s not long before all that poking leaves them feeling like a black-and-blue pin cushion.
Pradaxa’s secondary selling points, that it could help prevent stroke and supposedly has fewer side effects, have made it a doctor favorite, too.
The only trouble is this is yet one more case where the FDA got things VERY wrong. Their too-quick rubber-stamp approval on this risky drug may have put hundreds of thousands of lives in danger.
Serious, sometimes fatal, bleeding occurred
The first hint of trouble surfaced within two years of Pradaxa being on the market. The number of doctors reporting serious, sometimes fatal, bleeding problems in older patients on the drug skyrocketed.
Eventually the drug was blamed for over 500 deaths. There were reports of uncontrolled bleeding, and suits were soon filed against Boehringer Ingelheim.
Boehringer ended up settling more than 4,000 claims. They paid out over $650 million in suits claiming that the drug caused bleeding events that couldn’t be controlled, and were sometimes fatal. According to the FDA’s own records in 2011 alone over 540 patients died after using the blood thinner.
But even this couldn’t stop Pradaxa’s meteoric rise. It barely made a chink in the armor. Pradaxa, and its persuasive promise of no more blood tests, was invincible. That is, until a study published in 2014 began to raise more questions.
An investigation in the British Medical Journal raised some serious concerns about Pradaxa. I’d tell you that you’re never going to believe what their research uncovered, but I’m betting you’re beyond being shocked by Big Pharma’s antics.
In the report, the experts revealed that those who green-lighted Pradaxa (you know, the chuckleheads over at the FDA) never even saw some critical information that could literally mean the difference between life and death for many patients.
And why wasn’t this potentially lifesaving data ever handed over by the drug’s makers? You be the judge. The data that never made its way into the FDA’s hands was information showing that testing blood levels of the drug could greatly reduce major bleeding problems.
Bleeding problems slashed up to 40 percent!
In other words, the kind of monitoring that has always been done with the old stand-by Coumadin. And, of course, it’s the very kind of blood testing that Pradaxa promised to get rid of… the selling point that made Boehringer Ingelheim at least 30 billion bucks, and counting.
According to Thomas J. Moore, the senior scientist at the Institute for Safe Medication Practices who wrote an analysis to accompany the BMJ investigation, the claim by the company that the drug doesn’t need any blood-level monitoring is simply flat out misguided.
But when you consider that Boehringer held onto data for several years showing that Pradaxa’s blood-thinning effects varied between patients more than five-fold—and that monitoring and adjusting doses of the drug could drop major bleeding problems by 30 to 40 percent—I think Mr. Moore was being quite generous using the word “misguided.”
I could think of a lot better words to describe what they’ve done. And I’m betting the surviving bleeding victims, and the families of those who weren’t so lucky, sure could, too.
Did Boehringer put marketing before public safety? No knows for sure what the drug giant’s motivations actually were in holding back this critical information. But let’s just say that Big Pharma putting profits before people seems to be par for the course.
Dr. Allan Spreen
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