FDA caught ignoring safety problems with fast-tracked meds
Forget the Gang That Couldn’t Shoot Straight — when it comes to protecting us from dangerous drugs, the FDA is firing blanks!
For years the FDA has been promising us that its fast-track approval process wasn’t putting us at risk. It lets the agency sign off on so-called “breakthrough” new drugs at light speed, and study the safety problems later.
You know, once we’ve all become lab rats.
But it looks like our government has been lying to our faces all along. Because a new report proves that the FDA isn’t doing a thing to track serious problems with these new meds — including complications that could kill you.
It’s a problem that’s about to get a whole lot worse unless we act now to keep ourselves safe.
They warned that it could actually cut off the blood supply to your pancreas and do serious — and permanent — damage.
It’s the kind of danger that anyone taking the drug would want to know about. But if you’re expecting the FDA to help out, you’ve got some long, tough sledding ahead of you.
You see, Bayer got Nexavar approved as a thyroid treatment though the fast-track process, and the FDA promised to let us know all about the risks down the road.
But there’s one big problem. A new report from the Government Accountability Office (how’s that for an oxymoron) found that the FDA isn’t looking at or sharing this information on fast-tracked meds at all.
They may as well be throwing it in the trash!
The GAO studied eight years of approvals on fast-tracked drugs, and here’s what they found:
- The FDA didn’t post a single report about adverse events with fast-tracked drugs last year, which is against the law. Nothing. Nada.
- The agency doesn’t even have the data in a form that its staff can use to investigate potential dangers from drugs.
- And are you ready for the kicker? There are 1,400 post-market studies on these meds sitting in FDA headquarters right now that haven’t been fully reviewed!
“The GAO report confirms my greatest fear,” said Connecticut Representative Rosa DeLauro, who requested the study.
Greatest fear? This is a nightmare! The FDA isn’t even pretending to study the safety of these meds — drugs that may be sitting in your medicine cabinet right now — anymore.
And, believe it or not, the problem is only getting worse. The FDA signed off on nearly 40 different drugs through its fast-track or priority review processes just last year alone.
We’re talking about dozens more drugs that may be harming — or killing — people as we speak. And if our government has its way, we’ll never hear a peep about it.
One of those drugs is Entresto, the heart failure med that got the fast-track special last year, even though researchers were warning it could cause Alzheimer’s and macular degeneration. Looks like if it’s up to the folks at the FDA, there won’t be any more talk of that.
Rep. DeLauro said it’s clear that the FDA “lacks fundamental resources and leadership” it needs to make sure the drugs its unleashing on us are safe.
Well, I don’t know about the resources part — these guys are getting nearly $5 billion in our tax dollars a year.
But I can tell you a thing or two about the FDA’s leadership.
President Obama’s hand-picked appointee Dr. Robert Califf may be just days from taking the agency’s helm. And as I’ve told you before, he’s part of Big Pharma’s good-old-boy network who’s spent his career helping drug companies zip through the FDA approval process.
It’s clearer than ever that it’s up to us to keep ourselves safe — because the government isn’t going to do the job.
Here’s a list of drugs that got expedited approval (and maybe not a second look) over the years.
If you or someone you love is taking a med on this list, talk to your doc and get a full accounting of the risks.
And if all you get is a shrug in return, be sure to ask about alternatives.
Sources:
“FDA faulted for failure to track safety issues with drugs already on market” Sheila Kaplan, January 14, 2016, Stat, statnews.com
