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Business More Important Than Health at the FDA

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http://www.mercola.com/2006/mar/11/business_more_important_than_health_at_the_fd\

a.htm

 

 

Business More Important Than Health at the FDA

 

 

Despite a unanimous recommendation by FDA scientific staff not to

approve an implanted device used to treat depression.

 

Dr. Daniel G. Schultz, director of the Center for Devices and

Radiological Health at the agency, kept its application moving up the

ladder and eventually decided to approve it.

 

No Effect On Depression

 

The device in question is a surgically implanted vagus nerve

stimulator produced by Cyberonics Inc. In its one and only clinical

trial, it had no apparent effect on depression. This caused FDA

scientists to repeatedly recommend rejecting it.

 

" Safe and Effective " ?

 

Susan Bro, an FDA spokeswoman, claimed that the device had been

approved because of the seriousness of persistent depression.

Cyberonics argues that the device is the only " safe and effective "

option for chronic, treatment-resistant depression.

 

The vagus nerve stimulator is surgically implanted in the upper chest,

and stimulates a nerve leading to the brain. Side effects can include:

 

* Voice alteration

* Shortness of breath

* Neck pain

* Difficulty swallowing

* Heart problems

* Vocal cord paralysis

* Death

 

Reviewers Bewildered

 

Internal correspondence within the FDA show that reviewers were

bewildered by Dr. Schultz's continuing support for the device after

the complete failure of its clinical trial.

 

Houston Chronicle February 18, 2006

 

Spartanburg Herald-Journal February 17, 2006

 

Dr. Mercola's Comment:

 

I started posting about this story several months ago. It's yet

another great example among a litany of reasons you can't trust

officials at the FDA to protect you from corporate greed because they

are actually part of the system that promotes it.

 

One sentence about this from an internal FDA memo sums up why Dr.

David Graham was right about the culture at the FDA: " As an M.D.

interested in science, it seems to me that such an approval would be

akin to approving an experimental product. "

 

How could the FDA approve this device in the first place when its

clinical trial showed it had no effect whatsoever?

 

Frankly, it's because the FDA is in the pocket of big business, and

has been for years. More than 50 percent of the money the FDA spends

reviewing drugs comes from the drug industry itself.

 

A full 80 percent of the FDA's resources are geared toward the

approval of new drugs, and only 20 percent for all the rest. Only 5

percent goes to drug safety.

 

As a result, drugs and treatments that are ineffective or actively

dangerous are approved (often over the protests of the FDA's

scientific staff) if they'll make money for the FDA's drug company

" partners " . The FDA administration is a mass of conflict of interest,

with top officials shuttling back and forth between jobs in government

and the industry they're supposed to be regulating.

 

This climate at the FDA is causing an unprecedented amount of employee

turnover. Top scientists who have committed their lives to public

safety are being prevented from doing their jobs, and are either

giving up and quitting or being forced out.

 

Honest scientists are forced to reluctantly contribute to approval of

dubious drugs and treatments, or, in some cases, drugs are approved

against the investigators' recommendations.

 

Then their hands are tied as they watch these same drugs harm

thousands of people. It is not uncommon for respected FDA veterans to

leave the FDA having lost confidence in the safety or effectiveness of

prescription drugs. Morale at the FDA is at an all-time low.

 

News like the approval of this useless and dangerous device merely

reinforces just how broken this conventional health care model truly

is, and why more people are taking better responsibility for their

health by seeking alternative methods that treat their conditions more

safely.

 

As for depression, it's 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. Folks, this is not

the same thing as a cardiac pacemaker; your heart actually expects

some type of signal like this.

 

You can predict with virtual certainty that this technology is

guaranteed to fail because it in no way shape or form treats the

underlying cause of the problem. This product can only lead to

complications, side effects, more misery, deaths and let us not

forget, increased profits for the device manufacturer.

 

This is one technology you will want to avoid.

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