An invasive stroke therapy, used with a drug, is no more effective than the drug alone

Streamlined design

It was bound to happen sooner or later.

As we already know, the FDA is smitten with the idea of a streamlined approval process. Faster. Faster. Faster. Get those drugs and devices pushed through and approved.

But as skeptical as I am about the FDA, I never thought it would come to this…

Timing is everything

NPR reports that the FDA has approved an invasive medical device without clinical proof that it works.

Yes, apparently it’s THAT easy to get approval. I guess you just send a text message or something and they overnight it so you have it the next day.

Honestly, I don’t mean to make light of this. It’s actually quite serious. But I do want to make it sound just as ridiculous as it is. Because this device — approved without evidence that it has any value — may put stroke patients at risk.

And how do we know that? Because someone finally did the work that should have been done BEFORE approval. Recently, researchers conducted three different studies of this procedure. And three times, the clinical proof came up short.

If it walks like a scam and talks like a scam, I’m very tempted to call it a scam.

And that’s about the most generous way to put it.

The problem with this device is so simple, everyone involved should have seen it coming.

It’s called an endovascular therapy (ET). It travels through the artery to clear blockage that causes a stroke. And it works! But it only works within a narrow time frame. And that frame is almost impossible to hit.

First, doctors have to give a stroke victim a clot-dissolving drug called tPA. Ideally, this occurs within two hours of stroke onset. Then, if the tPA doesn’t work, specially trained doctors administer ET about 90 minutes later.

This is a perfect plan for anyone who has a stroke while in a hospital that has ET-trained personnel. But most stroke patients reach the hospital several hours after onset. At that point, the window is closed, or closing quickly.

The three new studies show that ET is no more effective than tPA alone when doctors administer it too late. And it’s almost always too late. Nevertheless, it still might be administered. Why? Because based on the misguided FDA approval, it’s covered by Medicare.

What’s worse is that ET is an invasive procedure. And when you put a device into an artery, things can go wrong. Especially with elderly patients. And most stroke patients are elderly.

This is what happens when a new device is hyped as a lifesaver and the FDA is in the mood to approve ASAP. Reality takes a backseat.

As usual, the patient is the loser.

Sources:
“Endovascular Therapy after Intravenous t-PA versus t-PA Alone for Stroke” New England Journal of Medicine, Online ahead of print 2/7/13, nejm.org

“Widely Used Stroke Treatment Doesn’t Help Patients” Richard Knox, NPR, 2/8/13, npr.org