FDA In Hot Water, Again

Because according to two new studies, these and other devices are little more than experimental procedures that never should have been approved in the first place.

You’d think – and hope – that medical devices that require cutting open your chest and implanting a foreign device in your body would undergo rigorous testing. And in fact, the FDA does require these high-risk devices to undergo the toughest of reviews before they’re approved… which is why I was shocked by the results of these two studies.

One study, published in the Journal of the American Medical Association, looked at the research used to approve 78 heart and blood vessel devices. Turns out that two-thirds of these devices were OK’d on the basis of a single study – and often one carried out overseas. Even the researchers were surprised at the lack of high-quality evidence behind them.

The other study, published in the American Journal of Therapeutics, found that 40 percent of these device studies lacked precise safety targets. The researchers also found that these studies left out key data, and even failed to account for some patients.

The FDA is in hot water over this one. Just this past August, the head of the division resigned when scientists who worked under him accused him of being pressured into approving certain devices. That would certainly explain a lot.

Congress has even stepped in, insisting that the FDA clean up its act pronto. In response, the FDA says it will release even tougher guidelines later this year. So what? What difference will tougher guidelines make if no one is bothering to enforce them?

But that’s not the only issue at stake here. In 2008, the U.S. Supreme Court sided with Big Pharma and Uncle Sam when it determined that it’s illegal to sue the manufacturer if a device caused injury.

Well no wonder the manufacturers aren’t worried about product safety! There aren’t any consequences if the devices fail to do their job – or even if someone dies as a result.

This is just one more reason to avoid surgery at all costs. It’s so commonplace these days that people assume there’s no risk. Let me clue you in… anytime you go under anesthesia, you’re putting your life at risk. And when you’re allowing the surgeon to implant an experimental device… it’s another roll of the dice.

And that’s a gamble I’m not willing to take.

For the new analysis, published in the journal Neurology, researchers looked at five studies. Three showed no benefit to TENS for back pain, while two showed some modest benefit.

Instead of concluding that we need more research, the American Academy of Neurology went ahead and issued guidelines that advised against using TENS to treat back pain. That’s not just wrong – that’s arrogant and irresponsible, and even some neurologists are rebelling.

“Absence of evidence is not evidence of absence,” two neurologists wrote in an accompanying editorial. “There seems to be considerable empirical evidence that, at least in some patients, TENS is useful.”

It’s true that there’s plenty we don’t know about how this treatment works. Some say it overstimulates your nerves and confuses the pain signals in your brain. Others say it’s a placebo effect.

But does it really matter? We’re talking about an inexpensive therapy that is perfectly safe, has no side effects, and doesn’t conflict with other drugs. And those who swear by it say they get near-instant relief.

Here’s my advice: If you’ve been using TENS and find it works for you, keep using it. And if you can’t find a good way to ease your own back pain and want to give it a try, don’t let these guidelines discourage you.

You can often get TENS treatment from a physical therapist or chiropractor. If you find it works, you can consider buying your own TENS device to use at home. You can get them for as little as $100. Talk to your doctor to find out if it’s an option for you.

In any case, even if TENS helps, it won’t be your ultimate answer – just a safe and drug-free procedure that may give you some relief. In the end, you’ll still need to get to the bottom of the cause of your back pain – whether it’s poor posture, too much time at a desk, an injury, or stress.

Just don’t fall for the drugs and surgery trap – both of them are recipes for more pain, and not just for your back.

On a mission for your health,

Ed Martin
Editor, House Calls