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.


    Dr. Mercola's Comments:

    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.

    Fortunately, you have access to some absolutely incredible tools 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.



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