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FDA Considers Implant Device for Depression (moved from ATSNN)

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posted on May, 22 2005 @ 06:49 PM
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A device which was first approved by the FDA in 1997 to treat epilepsy may soon land approval for treating depression. The $15,000 vagus nerve stimulator, which is similar to a pacemaker, must be surgically implanted. However, doctors say that it cannot be entirely removed. The wires leads which connect the device to the patient are usually left in the neck. Critics claim there is not enough evidence or case studies to show that the device works. Proponents point out that many severely depressed patients do not respond to medication or shock therapy, and that all avenues for treatment must be taken.
 



www.nytimes.c om
The Food and Drug Administration may soon approve a medical device that would be the first new treatment option for severely depressed patients in a generation, despite the misgivings of many experts who say there is little evidence that it works.

The pacemaker-like device, called a vagus nerve stimulator, is surgically implanted in the upper chest, and its wires are threaded into the neck, where it stimulates a nerve leading to the brain. It has been approved since 1997 for the treatment of some epilepsy patients, and the drug agency has told the manufacturer that it is now "approvable" for severe depression that is resistant to other treatment.

But in the only rigorously controlled trial so far in depressed patients, the stimulator was no more effective than surgery in which it was implanted but not turned on.



Please visit the link provided for the complete story.


While this device is not backed up by extensive clinical trials, experts say the nail is not in the coffin just yet. The FDA usually sides with the majority of its advisery panel, and many of those are strongly against this product. That being said, some patients have decided not to wait for FDA approval and have already had the device implanted. The company which produces it claims that it is more of a long-term treatment, and that 30% of participants in the study found it to be more effective after 6 months. Still, one epileptic patient found that when the implant was "turned up" she felt suicidal. Hopefully the FDA won't jump the gun and grant approval before more long-term studies are completed.




posted on May, 22 2005 @ 09:22 PM
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Hmmm.

There is significant evidence that (depression related) obsessive compulsive disorder may be triggered by a bacterial infection, specifically strep. If it is, then antibiotics are needed, not "mood" adjustments.

Can You Catch Obsessive-Compulsive Disorder?
www.nytimes.com...

IMO - there's big bucks in treating secondary symptoms - but it's time to stop looking at sick people as a "market" - and start getting serious about real medicine.

....There's a good chance that all 'mental illness' has a physical base in infections, likely obscure and complicated infections, but treatable and curable ones.



posted on May, 22 2005 @ 09:44 PM
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soficrow, you're an expert with that hammer. I'm so tired of the misery of mentall illness and certain physical ones which are 'treated' with everything but the one thing that will help: the cure.



posted on May, 22 2005 @ 09:44 PM
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NO no no. Depresion is a natural thing, but it's not like we've allready destroyed the nature around us. We treat anything that someone has as a diseas or a sickness, like ADD.
And now we want to take away depresion, some things, but, it is moving us foreward in a way in science. mm



posted on May, 22 2005 @ 09:46 PM
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NO no no means somewere in space a trail of disagreement got set through my ears and into my mind by some timelaps deal.



posted on May, 22 2005 @ 11:19 PM
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Thnx daboga. ...but many people don't want to hear it.


Surrealist - you say:


NO no no. Depresion is a natural thing, but it's not like we've allready destroyed the nature around us. We treat anything that someone has as a diseas or a sickness, like ADD.
And now we want to take away depresion, some things, but, it is moving us foreward in a way in science. mm


IMO - sadness is natural, and grief. Anger and fear, yes. But depression? I don't think so.

When the epidemics started spreading in the 1940's and 50's, people knew they were sick. But doctors labelled the symptoms "depression," and hypochondria - even though they knew they were dealing with weird new (physical) disease mutations - because the new diseases were incurable and untreatable.

Then the drug companies came up with Valium and drugged the nation. Especially the women. Cuz women had time to observe, and a tendency to share intimate information and medical details about their families' health.

The 'women's movement' supported the AMA and drug companies - agreed that women were nuts and neurotic - and blamed 'lifestyle' and a lack of professional productivity. So they sent all the drugged women off to work and left the doctors in charge of families' health instead of concerned, aware mothers, who had the time to notice what was really going on.

In the early 60's, the US pulled the plug on funding to the 'global morbidity and mortality stats' compilation program. The funding wasn't reinstated until the end of the 1980's, under extreme pressure from independent family doctors.

By that time, most people were thoroughly convinced that infectious disease was "conquered." And besides, decision-makers argued, it was too late to get it all under control. Better to let people "evolve" and adapt, and count on "survival of the fittest."

...We have changed our world fundamentally - chemically, biologically, and genetically. And now we're dealing with the fallout. Part of that fallout is new microbes and disease mutations, no natural immunity, and secondary symptoms labelled "mental disease."

Did you know? ..."Clinical depression" is the leading cause of disability in the USA today - and the World Health Organization says it will be the leading cause of disability in the world within the next few years.

...Two primary symptoms of "clinical depression" are migraines, and body pain for which there is no physical explanation.

Also of note:

1. A disease called fibromuscular dysplasia (FMD) is epidemic in the USA - it is a "systemic angiopathy" that destroys the blood and lymph vessels, usually very slowly, and can affect virtually any organ, gland, system and body part (stroke, heart attack, cancer, and kidney failure are the most common fatal effects);

[See: www.abovetopsecret.com... ]

2. A 1980 biopsy study in China showed that 100% of migraine patients had FMD; and

3. As FMD progresses, it causes painful vasospasms and ischemia that can affect any part of the body - but because FMD bypasses the immune system, there are no blood tests or other routine clinical tests that reveal its presence - and insurance does not cover the expensive tests until a life threatening event occurs.

...IMO - it's ALL physical. Not mental. And definitely NOT "natural."





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