Big Pharma wins reprieve for highly risky med after 3 FDA rejections
It failed its clinical trials. Its manufacturer was accused of “ethical lapses” during tests that may have killed heart patients. It was even rejected by the FDA three times.
And now the deadly new blood thinner Cangrelor is headed straight for a hospital near you.
When I first warned you about Cangrelor this spring, I told you how even the country’s top cardiologists were worried that it could trigger fatal bleeding. How it may even be more likely to cause a hemorrhage than save a life.
Now the FDA has approved the drug based on shoddy science and a new label that isn’t worth the paper it’s printed on. And if you or someone you love is scheduled for heart surgery, it’s never been more important to learn how to avoid becoming Cangrelor’s next victim.
But when the FDA recently approved Cangrelor, all it got was a reworded label. One that’s a shade away from being meaningless, because now that the drug is available your doctor is allowed to use it in any way he sees fit.
Which is why you need to know what went on behind the scenes and why it’s so important to avoid the drug. Because, as one expert put it, “this smells bad.”
When the Medicines Company set out to do its big trial called CHAMPION on Cangrelor, the company pulled a devious trick.
You see, to make Cangrelor look good, the researchers conducting the study apparently delayed administering competing drugs to patients. Some may have died just to make Cangrelor appear more effective.
That was something the FDA’s lead medical reviewer found “very disturbing.” And he said that even though the CHAMPION trials couldn’t prove that Cangrelor was in any way superior, it did prove one thing: it posed very real risk of deadly bleeding.
Another expert, Dr. Milton Packer, who is one of the country’s top cardiologists, predicted that Cangrelor is just as likely to cause life-threatening internal bleeding as it is to save someone’s life. He added that our government shouldn’t sign off on drugs based on what “they ought to do and hope they would do.”
But that’s exactly what the FDA did when it finally caved to pressure from the Medicines Company and agreed to approve Cangrelor. All the company had to do was to make a new label that would limit how the med would be used.
The FDA approved Cangrelor for a “smaller subset” of patients, those who are undergoing a coronary angioplasty. Dr. James A. de Lemos from the University of Texas, said that Cangrelor should only be a “niche drug,” and not one that is “widely used.”
But even if doctors stick to that smaller group… which they’re not obligated to do… it will still put around half a million people at risk every year. And that’s according to the FDA’s own numbers!
Hardly what I’d call a niche.
If your doctor decides to use Cangrelor, it will be administered in a hospital or clinic setting. And as you know, it’s very difficult to keep track of what drugs you’re being given in that kind of situation.
So if you’re scheduled to have any kind of procedure to open blocked or narrowed arteries, it’s important to talk to your doctor about Cangrelor as soon as you can. And make sure he understands the shady history behind this drug as well as you do.
Sources:
“FDA approves Cangrelor for reducing thrombotic events in PCI setting” Michael O’Riordan, June 22, 2015, Medscape, medscape.com
“FDA approves Medicines Co’s blood clot drug after a decade” Reuters, June 22, 2015, Yahoo News, news.yahoo.com
