It’s the biggest scandal you haven’t heard of — a massive public health bombshell waiting to explode.
And the FDA itself MADE IT HAPPEN!
The agency has been on an approvals kick lately, rubber-stamping practically everything that comes its way, even when its own experts urge them to say “NO!”
As a result, a new analysis finds a surge in the approvals of critical heart treatments, even when there’s no solid evidence they work.
The new report in Medscape finds no less than SIX new heart devices that flunked their own clinical trails… but were approved anyway.
In research for a non-metal, dissolving type of heart stent called the Absorb bioresorbable scaffold stent, “all the endpoints went in the wrong direction,” according to Medscape.
An implantable heart device called Watchman “did not meet both co-primary endpoints.”
CardioMems had shenanigans in the study, causing the FDA to order new research. The company instead continued with the flawed trial.
Should I go on? At least three other devices had serious problems in research but are on the market or headed there right now anyway, according to Medscape.
This isn’t some “out there” rabble-rousing group of troublemakers (like yours truly). Medscape is as mainstream as they come — a leading source of news and information for medical professionals.
When Medscape calls out to Houston to say we’ve got a problem, you can bet your stents there’s a problem.
In this case, it’s not just ineffective treatments.
It’s that patients who choose “shiny and new” don’t get the “tried and true.” And when “shiny and new” fails, it’s usually too late to go back and get “tried and true.”
You’re already dead.
And yet thousands — maybe MILLIONS — of Americans are in line for these new devices.
All this is happening because of something I warned you about last year right here in the Daily Dose: the decision to put Dr. Robert Califf in charge of the FDA.
This guy isn’t on the side of patients. He’s a Big Pharma hack who’s made a career of helping the industry get its stuff crammed through approvals as quickly as possible.
Now that he has the keys to the store, he’s marching them through faster than ever — evidence be damned — and American patients could be about to pay the price in a big way.
So, if you’re a heart patient and your doc is pushing some fancy new device, DEMAND to see the evidence — then, go home, get on the computer and do your own research before you decide.
And for your best shot at beating heart problems without surgery, work closely with a skilled naturopathic medical doctor.
I recommend an experienced member of the American College for Advancement in Medicine.