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Controversial Brain Stimulator Approved for Depression
Posted by: Dr. Mercola
August 04 2005 | 918 views

Technology appears to be taking over the medical realm, for the Food and Drug Administration (FDA) has approved a device known as the vagus nerve stimulator, or VNS, as a potential treatment for an estimated 4 million Americans with treatment-resistant depression.

The device received the stamp of approval, however, despite controversy over whether it has really been proven to work.

Questioned Validity

The therapy is carried out by implanting a pacemaker-like generator into the patient's chest; wires twist up the neck to the vagus nerve, sending tiny electric shocks through that nerve and into a region of the brain thought to play a role in mood.

An FDA review of the therapy last year found no difference in depression after three months of implant treatment in a 200-patient study. However, Cyberonics, the Houston-based medical device manufacturer, argued that a year after a notable number of the VNS recipients experienced an ease in their depression.

That yearlong follow-up hadn't been carried out according to standard scientific procedures though (it wasn't a randomized control study) and, thus, critics questioned its validity. It was further argued that without a comparison group, it remains unclear if the implant really worked or if the depression was eased by some other factor.

VNS Risks

Not surprisingly, many recipients of the therapy have suffered a host of adverse side effects:

  • More than half of patients in the depression study experienced at least temporary voice alterations--a hoarseness or raspiness, or voice "breaks"--that seemed to persist in a significant number.

  • Other complications included difficulty breathing or swallowing.

Yet the device was still FDA approved.

According to the director of the FDA's device center, VNS would carry the strongest warning possible, a black-box warning, cautioning patients that the device is permanent.

USA Today July 17, 2005


Dr. Mercola''s Comments
Dr. Mercola's Comments:
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One of the wonderful undeniable aspects of technology is that we are getting more and more of everything faster and faster. One of my best mentors in this area is Dr. Richard Swenson who is a teaching physician at the University of Wisconsin and with the Christian Medical Society.

He wrote a book 10 years ago that has been enormously useful in my own life, and it expands on this principle. The book was, Margin: Restoring Emotional, Physical, Financial, and Time Reserves to Overloaded Lives, but he has a newer version of the book out called A Minute of Margin: Restoring Balance to Busy Lives.

The book has been enormously helpful for me to strive to always keep my schedule somewhat open and to learn to say no to many good opportunities in life so I can have enough "margin" or flexibility in my schedule to respond to unexpected opportunities.

Anyway, that was a tangent to one of the central issues that Dr. Swenson teaches and has been even more evident since he wrote the original Margin book 10 years ago. We can expect technology to exponentially advance. But just because it is advancing it does not necessarily mean that we are receiving a benefit.

The new device the FDA approved is an absolutely classic example of this principle.

Depression is a serious issue and if you are wondering how to diagnose or treat it from a natural perspective, I would encourage you to review my previous comments on that.

Just because we now have the technology to implant a device into someone's brain does not mean that we should do it. I am a great believer in technology, but it is difficult for me to envision a technology in the next few hundred years that would ever be appropriate for this purpose.

How can I be so confident?

Easy. Let me share the principle so you too can start to learn how to interpret these studies when you see them in the media. This approach in no way, shape or form treats the cause of the problem. So no matter how great or wonderful the technological solution, if it does not treat the cause you need to seriously consider the validity of the approach.

I haven't even begun to speculate on the potential side effects of this technology. There are the obvious ones of infection from introducing any foreign body, but, more importantly, do we have any idea of the long-term results of introducing long-term electric shocks into your brain?

Folks, this is not the same thing as a cardiac pacemaker, which expects some type of signal like this. This is a foreign energy that is being introduced into your brain and could have all sorts of potential side effects that are not yet appreciated. This is one technology you will want to avoid.

Now sometimes you don't have a choice, as in the case of a soldier that has his legs blown off. Since we can't currently turn back time and move the solider from the explosion that caused the problem we need a technological solution.

Fortunately, we have some absolutely incredible technologies for depression that are free and work far better and more quickly than this implant. They are tools based on energy psychology and by far the best one of these from my perspective is the Emotional Freedom Technique (EFT), which is a gentle tapping technique based on needle-less acupuncture. You can download my free manual on this for more information.

But how could the FDA approve this type of device in the first place when the original data submitted for approval showed that there was NO DIFFERENCE after three months of implant treatment?

Well, that sure is an interesting question isn't it? There are many reasons behind this, and I will shortly be running an interview with my hero and one of the most courageous health leaders of the 21st century: Dr. David Graham. He is the physician who blew the lid on the FDA and Merck in his testimony to Congress on the Vioxx scandal. I am pleased that I was able to personally connect with Dr. Graham and now have an alliance with him.

He has helped write new legislation called the Grassley Dodd Bill that is currently held up in committee. It is a radical bill that should help transform the FDA back to its roots and really protect the public's safety. It would set up a new independent center inside the FDA to review drugs and biological products once they are on the market.

The bill addresses the fact that the office of new drugs carries too much sway over the FDA's drug-safety apparatus. Today, drug makers have the ability to negotiate with the FDA officials who approved their drugs to begin with when the FDA considers corrective action. By creating a center for post-market review, this legislation puts you, the American consumers, where you belong at the FDA, and that's front and center.

I don't ask you to write your congressman frequently, but this one is worth it. You can help save some lives by helping to increase pressure to change the way the FDA is run. The drug companies do NOT want this bill passed, and they have the largest lobby in Congress so we really need all the help we can get.

You can find out how to contact your Congressman by going to the US House of Representatives Web site.

All you need to do is write a simple short note telling them how you feel the FDA is critically broken and you believe that the new proposed legislation would really help improve that.

If you want to review the entire bill, I put it up on my site.

Related Articles:

Exercise Better Than Drugs For Depression

How To Beat Depression and Boost Your Mood With Foods

Sugar and Grains Increase Depression





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