New legislation would give free passes to dangerous medical devices
It’s a dangerous bill that’s guaranteed to kill — and it may be just weeks from becoming law.
Since last year I’ve been warning you about the 21st Century Cures Act — a piece of legislation with Big Pharma’s grubby fingerprints all over it.
The way it’s written now, the 21st Century Cures Act would keep you from being able to buy low-cost generics, and would let drug companies market their meds for diseases they were never meant to treat.
But it looks like the free-for-all doesn’t stop there.
Because the medical device industry has snuck a terrifying provision into the bill that would allow them to sell pacemakers, heart valves, and other vital medical devices that have barely been tested and have never been reviewed by the FDA.
It’s the kind of thing that will put you and the people you love right in harm’s way — and if we don’t act fast, it’s about to become the law of the land.
But with all the fat checks these device manufacturers hand out to members of Congress, we should have known better.
You see, there are laws in place right now for so-called Class III medical devices. These are things that will kill you if they break, and they have to go through the same approval process as prescription drugs.
And we all know what a shoddy system that is — but it’s about to get a whole lot worse.
Section 2222 of the 21st Century Cures Act would allow — actually encourage — the FDA to give approval to these risky devices solely using medical journal articles as proof that they work.
And there’s a problem with that. A very big problem.
You see, relying on that kind of information is like asking a fisherman to tell you how big a fish he caught.
It’s filled with errors, prejudice and downright fraud. In fact, just a few days ago I told you how journal articles were regularly failing to report serious drug side effects, including deaths.
And if you want to see how medical device manufacturers game the system, you don’t have to look any further than the Medtronic spinal fusion device.
This was supposed to be the “new and improved” way spinal fusions would be done. Instead of taking a bone graft from a patient’s hip, Medtronic used an implantable metal “cage” filled with a collagen sponge to kick-start bone growth.
The journal articles were so glowing you would have thought the Medtronic device was the greatest thing since sliced bread.
Only it wasn’t. Patients were suffering chronic pain, getting bizarre bone growth and even cancer from the device. Some even died.
As it turned out, the lion’s share of the journal reports were a sham, composed by either the man who invented the device (and published in a journal he edited) or written by doctors paid to promote it.
And that’s just one example of “peer-reviewed” journal fraud that’s become rampant.
But should Section 2222 go forward, device-makers won’t even have to go that far.
It would also allow the FDA to approve these high-risk devices based on “well-documented case histories.” Translation: An anecdote about how a device worked on a patient.
Look, in the last year we’ve seen stories proving how shaky this system is already. I’ve told you about power morcellators, for example, that can spread uterine cancer and those surgical scopes that are breeding grounds for deadly superbugs.
And if the 21st Century Cures Act becomes law, you’re going to be hearing a lot more horror stories like these.
The House has already passed its version of the bill. Now it’s in the Senate, where it could move soon.
Unless, of course, we stop it. Write your senators today and tell them to vote against the 21st Century Cures Act.
Demand that they kill this bill once and for all — before it starts killing innocent Americans.
Sources:
“A risky shortcut” Public Citizen, February 9, 2016, citizen.org
