There’s a fundamental medical right… maybe the most important freedom you have… that’s under attack right now in hospitals, clinics and doctors’ surgeries.
It’s called informed consent. It means that no doctor should hand you a prescription or perform a medical procedure until you’re fully aware of the risks.
But I can’t tell you how many patients I’ve met (and I bet you know some, too) who are taking a fistful of prescriptions each day, and they can barely tell you what they’re all for.
And when you visit friends or loved ones in the hospital and ask what’s in their IV bags, lots of times they have no idea.
That’s more frightening now than ever. Because in just a few weeks’ time, many patients hospitalised for heart procedures will be given one of the most dangerous anti-clotting drugs the American Food and Drug Administration (FDA) has ever approved.
Worse still, most of them will never fully understand the drug’s risks — or its disturbing history.
The FDA has just given the official greenlight for an intravenous drug called cangrelor (the brand name Kengrexal in the UK and EU, and Kengreal in the US) to hit the market. And while, after three decades of practicing medicine, it takes a lot for the FDA to surprise me, this sure did the trick.
Previously we told you how cangrelor failed two clinical trials and was soundly rejected by an FDA advisory panel last year. Concerns were raised at that time that a third cangrelor study included doctored results, and that the people who didn’t get the drug received substandard care.
One leading cardiologists warned that the drug may be just as likely to cause a serious, life-threatening bleed as prevent a subsequent heart attack or death.
But with an estimated $200 million in sales, cangrelor’s maker The Medicines Co. didn’t give up the ship easily. It kept resubmitting the drug for approval — even using data from the questionable study — and some of cangrelor’s harshest critics were removed from reviewing the drug.
What’s most alarming about cangrelor is that it will be given in hospital settings, post-surgery. That’s a time when it’s very difficult for patients to fully comprehend anything that’s going on with their care, much less question the drugs they’re being given.
Cangrelor is available in the UK and has hit the US market in June this year. So, if you’re heading in for heart surgery, it’s important to understand all the drugs you’ll be given, or to ask a loved one to serve as your advocate. I believe that anyone who is fully informed about the risks and history of cangrelor would want the drug as far away from them as possible.Wishing you the best of health,
Dr. Glenn S. Rothfeld
Nutrition & Healing
FDA finally approves Medicine Co.’s blood thinner Kengreal, pharmatimes.com