If killing part of your brain in return for milder symptoms of a non-life-threatening problem sounds like a good deal to you, don’t bother to read the rest of this. If destroying part of your brain sounds like a high price to pay for anything or like the plot of a mad scientist movie, then read on. Because the FDA just approved a new ultrasound “treatment” that does just that.
And they based that approval on a trial that included a whopping 76 people.
That sure makes me feel safe. It just gives me the warm fuzzies knowing that there’s a government agency that cares so much about my health. I feel so much better knowing what rigorous scientific study new gadgets and surgeries go through before they go into everyday use. After all, if it was used on 76 people and none of them actually died, then surely it’s completely safe. Right?
Every once in awhile I think I’ve passed the point of being surprised by Big Medicine or Big Pharma. But just when I begin to believe that I’ve seen it all, I’m surprised anew at the lack of concern FDA, NIH, USDA, and all the other alphabet groups with a finger in the healthcare pie have for our actual health. No matter how well I know that it’s all about money, sometimes I’m still shocked.
This is one of those cases. The FDA just approved a new “focused ultrasound device” to treat a problem called essential tremor. Now don’t get me wrong. This is a very real problem. It’s a neurological condition that causes uncontrollable tremors or shaking in part of the body—usually the hands or head. It can be terrible to live with. But is destroying part of your brain with an unproven technology really the answer? Especially when it appears that it’s only a temporary treatment?
Effective treatment or medical fad?
No one wants to admit it, but medicine is prone to fads. Each decade has its “in” treatment for different conditions. When they’re surgical fads, there’s often little evidence that they even work. A surgeon does a procedure, tells his buddies, and pretty soon everyone is doing it. Often these fads become standard treatment with no one ever doing any real testing on them.
For example: Lobotomies were all the rage in the 40s and 50s—the inventor even won a Nobel Prize. Today we’re horrified by the idea. Arthroscopic knee surgery for arthritis was the fad procedure of the 90s—but studies after the fact have found it pretty useless. There are diagnosis fads (carpal tunnel syndrome) and drug fads (Prozac). Medical faddism, as I like to think of it, is a real problem. In fact it seems like medicine loves its gadgets as much as the general population, and any new device will be a favored tool for a few years no matter what the evidence of its effectiveness.
Because doctors want all the cool new toys too.
I think that’s what we’re seeing right now with “focused ultrasound devices” like the one in question. A very useful tool in some cases but also an incredibly expensive one, the manufacturers are taking a page from Big Pharma’s book and pushing it for every possible use imaginable. Including scrambling your brain.
The technology isn’t new, but using it on your brain is
Ultrasound has been around for a long time. So-called “focused ultrasound” is newer, but it’s still been in use for over a decade. It’s used to get rid of uterine fibroids, a type of benign tumor that afflicts some women. It’s been used to treat the pain of bone cancer. It was approved to treat prostate cancer last year. But using it in the brain is a new thing. Here’s the deal:
Science isn’t really sure what causes essential tremor. It tends to run in families. There’s no underlying disease. It can look like Parkinson’s or MS to the casual observer, but it’s not. People simply shake uncontrollably—anything from mild tremors to debilitating shaking that interferes with daily activities. But no one really knows why.
Scientists believe that it’s an electrical problem in the brain. They think neurons are “misfiring,” so to speak. And they think the part of the brain responsible is the thalamus, a tiny area. But they’re not sure.
There are a variety of drugs people can try that often help. There are also non-drug treatments, including stress management. (Stress makes the problem worse.) And when all else fails, some people opt for surgery. There are two surgical options. The first is Deep Brain Stimulation (DBS), in which an electrode is implanted in the thalamus and disrupts the electrical activity in the area. It gives “moderate relief” to about 90% of people, lasts indefinitely (provided external hardware is replaced every five years or so. It doesn’t damage brain tissue.
The second option is to surgically destroy the thalamus. Although it’s more dangerous than DBS, symptoms are often completely relieved. The focused ultrasound treatment does the same thing—destroys the thalamus—but appears to be more likely to cause side effects than traditional surgery. And it doesn’t seem to be as effective. And…it looks like the “relief” begins to wear off within a year.
The people in this study—all 76 of them—had a mere 50% reduction in symptoms (on average) 3 months after treatment. (Compared to “complete or near-complete” relief with surgery.) But at the one-year mark, when the study ended, that had dropped to 40%. At this rate, the effect would be negligible in just a couple of years. That seems a steep price for destroying an entire brain region. And the possible side effects were nothing to sneeze at. They included:
- Numbness or tingling in the fingers.
- Balance problems.
- Loss of control of body movements.
- Problems with walking.
In some people the side effects resolved themselves, but a handful were left with what appeared to be permanent problems. And in an earlier safety trial of fifteen people, four were left with long-term negative side effects…which, if you do the math, is over one-quarter of the people who had the procedure. Other problems in both trials included burns, scarring, damage to other parts of the brain, hemorrhage, and blood clots.
And yet, FDA says this is safe and effective.
I’m not convinced.
It’s not quite an ice pick in the brain, but it’s close. I can imagine that some day we’ll look back on this particular medical fad and say, “My God, what were we doing?” In the meantime, here’s my advice: If you have essential tremor and your symptoms are unbearable--if they haven’t responded to non-surgical treatment or even drugs, opt for DBS. Because once you destroy part of your brain, it’s gone forever.
You only get one brain. Keep it.